before the independent citizens' oversight committee …€¦ · for alpha clinics request for...

BEFORE THE

INDEPENDENT CITIZENS' OVERSIGHT COMMITTEETO THE

CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINEORGANIZED PURSUANT TO THE

CALIFORNIA STEM CELL RESEARCH AND CURES ACT

REGULAR MEETING

LOCATION: HILTON SAN FRANCISCO AIRPORT BAYFRONT 600 AIRPORT BOULEVARD BURLINGAME, CALIFORNIA

DATE: JULY 25, 2013 9 A.M.

REPORTER: BETH C. DRAIN, CSR CSR. NO. 7152

BRS FILE NO.: 92760

I N D E X

ITEM DESCRIPTION PAGE NO.

REPORTS & DISCUSSION ITEMS

1. CALL TO ORDER. 4

2. PLEDGE OF ALLEGIANCE. 4

3. ROLL CALL. 4

4. CHAIRMAN’S REPORT. 6

5. PRESIDENT’S REPORT. 13

ACTION ITEMS

6. CONSIDERATION OF UPDATE REGARDING 53STATUS OF STRATEGIC PLAN ONE-YEAR GOALS, INCLUDING OUTCOMES FROM CURRENT PROGRAMS AND CONSIDERATION OF NEW ONE-YEAR GOALS.

7. CONSIDERATION OF CONCEPT PROPOSAL 68FOR ALPHA CLINICS REQUEST FOR APPLICATIONS.

8. CONSIDERATION OF CONCEPT PROPOSAL 132FOR TOOLS AND TECHNOLOGIES III REQUEST FOR APPLICATIONS.

9. CONSIDERATION OF EXTENSION OF, AND 146ALLOCATION OF ADDITIONAL FUNDS FOR, RESEARCH LEADERSHIP PROGRAM.

10. CONSIDERATION OF APPOINTMENT OF NEW 167SCIENTIFIC MEMBERS TO THE GRANTS WORKING GROUP AND REAPPOINTMENT OF EXISTING MEMBERS.

11. CONSIDERATION OF ADOPTION OF INTERIM NOT HEARDREGULATION REGARDING COVERED STEM CELL LINES.

12. CONSIDERATION OF ALLOCATION OF 168ADDITIONAL FUNDS FOR CONFERENCE GRANT PROGRAM FOR FY 2013-2014.

2

160 S. OLD SPRINGS ROAD, SUITE 270, ANAHEIM, CALIFORNIA 92808

1-800-622-6092 1-714-444-4100 EMAIL: [email protected]

BARRISTERS' REPORTING SERVICE

I N D E X (CONT'D.)

13. CONSIDERATION OF RESOLUTION HONORING 120DR. PHILIP A. PIZZO.

DISCUSSION ITEMS

14. UPDATE REGARDING COLLABORATIVE 173FUNDING PARTNERS PROGRAM.

15. UPDATE REGARDING IMPLEMENTATION OF 189 PERFORMANCE AUDIT RECOMMENDATIONS.

16. COMMUNICATIONS UPDATE. 193

17. PUBLIC COMMENT NONE

3




BURLINGAME, CALIFORNIA; THURSDAY, JULY 25, 2013

9 A.M.

CHAIRMAN THOMAS: AS YOU MAY HAVE NOTICED,

WE MOVED THE SPOTLIGHT TO FIRST THING IN THE MORNING

AS OPPOSED TO OVER LUNCH. AND WE FOLLOWING THAT NOW

WILL OFFICIALLY CALL THE MEETING TO ORDER. AND,

MARIA, WILL YOU PLEASE LEAD US IN THE PLEDGE OF

ALLEGIANCE.

(THE PLEDGE OF ALLEGIANCE.)

CHAIRMAN THOMAS: MARIA, WOULD YOU PLEASE

CALL THE ROLL.

MS. BONNEVILLE: LARS BERGLUND.

DR. BERGLUND: HERE.

MS. BONNEVILLE: DAVID BRENNER.

DR. BRENNER: HERE.

MS. BONNEVILLE: ANNE-MARIE DULIEGE.

DR. DULIEGE: HERE.

MS. BONNEVILLE: MARCY FEIT.

MS. FEIT: HERE.

MS. BONNEVILLE: LEON FINE.

DR. FINE: HERE.

MS. BONNEVILLE: MICHAEL FRIEDMAN.

DR. FRIEDMAN: HERE.

MS. BONNEVILLE: MICHAEL GOLDBERG. SAM

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HAWGOOD.

DR. HAWGOOD: HERE.

MS. BONNEVILLE: STEPHEN JUELSGAARD.

SHERRY LANSING. BERT LUBIN. MICHAEL MARLETTA.

LLOYD MINOR.

DR. MINOR: HERE.

MS. BONNEVILLE: FRANCISCO PRIETO.

DR. PRIETO: HERE.

MS. BONNEVILLE: CARMEN PULIAFITO.

DR. PULIAFITO: HERE.

MS. BONNEVILLE: ROBERT QUINT.

DR. QUINT: HERE.

MS. BONNEVILLE: DUANE ROTH. AL ROWLETT.

MR. ROWLETT: HERE.

MS. BONNEVILLE: JOAN SAMUELSON.

MS. SAMUELSON: HERE.

MS. BONNEVILLE: JEFF SHEEHY.

MR. SHEEHY: HERE.

MS. BONNEVILLE: OSWALD STEWARD.

DR. STEWARD: HERE.

MS. BONNEVILLE: JONATHAN THOMAS.

CHAIRMAN THOMAS: HERE.

MS. BONNEVILLE: ART TORRES.

MR. TORRES: HERE.

MS. BONNEVILLE: KRISTINA VUORI.

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DR. VUORI: HERE.

MS. BONNEVILLE: EUGENE WASHINGTON. DIANE

WINOKUR.

MS. WINOKUR: HERE.

CHAIRMAN THOMAS: THANK YOU. BEGIN WITH

OUR CHAIR'S REPORT. AS EVERYBODY KNOWS, OUR HIGHLY

ESTEEMED COLLEAGUE DUANE ROTH WAS IN A SERIOUS

BICYCLE ACCIDENT LAST SUNDAY. HE IS IN THE BEST

POSSIBLE CARE DOWN AT UCSD. AS WAS REPORTED IN THE

PRESS, WAS IN A MEDICALLY INDUCED COMA FOR A COUPLE

OF DAYS AS A PREVENTIVE MEASURE TO HELP SPEED

RECOVERY. AND WHAT WE HEAR FROM THE FAMILY IS THAT

THERE HAVE BEEN SOME POSITIVE SIGNS IN THE LAST DAY

OR SO, BUT THAT THE FAMILY WISHES THAT PRIVACY BE

MAINTAINED FOR DUANE AND THE FAMILY GOING FORWARD.

AND WE WILL KEEP EVERYBODY POSTED HERE AS TO HIS

PROGRESS AS WE HEAR ABOUT IT. AND OBVIOUSLY OUR

THOUGHTS AND PRAYERS ARE WITH DUANE AND HIS FAMILY

AT THIS TIME.

AS YOU NOTICE, WE HAVE DUANE'S POSITION

HERE PROMINENTLY TO MY RIGHT AS ALWAYS, AND IT WILL

REMAIN THERE UNTIL HE IS ABLE TO REJOIN US, WHICH WE

HOPE WILL BE AS SOON AS POSSIBLE AND THAT THAT WILL

BE VERY SOON. SO, DUANE, I DOUBT YOU'RE LISTENING

TO THIS; BUT ON THE OFF CHANCE YOU HAVE THIS PIPED

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INTO YOUR HOSPITAL ROOM, EVERYBODY IS THINKING OF

YOU AND SENDING BEST WISHES FOR A SPEEDY RECOVERY.

WE HAVE A NUMBER OF NEW MEMBERS HERE IN

ATTENDANCE. I'M GOING TO INTRODUCE THEM AND PERHAPS

EACH COULD SAY A BIT ABOUT THEMSELVES AND THEIR WORK

SO THAT OTHER MEMBERS OF THE BOARD AND MEMBERS OF

THE AUDIENCE WILL GET TO KNOW THEM A BIT BETTER.

WE'LL START WITH LARS BERGLUND FROM UC DAVIS.

DR. BERGLUND: THANK YOU VERY MUCH. SO

I'M AN ALTERNATE MEMBER. I'M THE SENIOR ASSOCIATE

DEAN FOR RESEARCH AT THE SCHOOL OF MEDICINE. I AM

THE DIRECTOR OF THE CLINICAL AND TRANSLATIONAL

SCIENCE CENTER AT UC DAVIS. MY OWN INTEREST IS IN

CARDIOVASCULAR DISEASE PREVENTION AND METABOLIC

DISORDERS.

CHAIRMAN THOMAS: THANK YOU. DEAN LLOYD

MINOR FROM STANFORD.

DR. MINOR: THANK YOU VERY MUCH. I'M

LLOYD MINOR. I'M THE DEAN OF THE STANFORD

UNIVERSITY SCHOOL OF MEDICINE. I MOVED OUT TO

STANFORD FROM JOHNS HOPKINS UNIVERSITY WHERE I HAD

BEEN THE PROVOST OF THE UNIVERSITY, AND THEN PRIOR

TO THAT THE CHAIR OF THE DEPARTMENT OF

OTOLARYNGOLOGY, HEAD AND NECK SURGERY AT JOHNS

HOPKINS. I MADE THE MOVE TO STANFORD IN SEPTEMBER

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OF 2012, BECAME DEAN ON DECEMBER 1ST. AND IT'S A

GREAT PRIVILEGE AND PLEASURE TO BE HERE. THANK YOU.

CHAIRMAN THOMAS: AND LAST, BUT NOT LEAST,

AL ROWLETT, OUR NEW PATIENT ADVOCATE FOR MENTAL

HEALTH DISEASE AND CONDITIONS.

MR. ROWLETT: GOOD MORNING. IT'S A

PRIVILEGE TO REPRESENT THE CITIZENS OF THE STATE OF

CALIFORNIA AND TO BE HERE WITH ALL OF YOU. LOOKING

FORWARD TO BEING ABLE TO MAKE MORE SUBSTANTIVE

CONTRIBUTIONS IN THE VERY NEAR FUTURE. I'VE BEEN

INVOLVED IN MENTAL HEALTH FOR OVER 32 YEARS IN THE

PRIVATE SECTOR IN A COMMUNITY-BASED ORGANIZATION AND

AM DELIGHTED TO BE PART OF THIS ORGANIZATION.

CHAIRMAN THOMAS: THANK YOU. AND,

GENTLEMEN, A HEARTY WELCOME TO THE BOARD, AND I

THINK YOU WILL FIND IT TO BE A MOST INTERESTING AND

REWARDING UNDERTAKING. SO THANK YOU FOR YOUR

PARTICIPATION. WE GREATLY APPRECIATE IT.

OVER THE LAST FEW WEEKS, I'VE HAD THE

PRIVILEGE OF ATTENDING A NUMBER OF MEETINGS WHICH

SORT OF SPAN THE BREADTH OF THE SCIENTIFIC COMMUNITY

AS WE KNOW IT IN THE STEM CELL WORLD. ON THE ONE

HAND ALL THE WAY TO AND INCLUDING THE ISSCR ANNUAL

MEETING IN BOSTON, WHICH, AS ALWAYS, WAS A

FASCINATING COMBINATION OF PRESENTATIONS ON THE

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CUTTING-EDGE WORK THAT'S GOING ON WORLDWIDE IN THE

SPACE.

I WILL NOTE AS AN ASIDE WE HAD OUR ANNUAL

COLLABORATIVE FUNDING PARTNER LUNCH, WHICH OUR

COLLEAGUE IAN SWEEDLER LED AND WILL BE SAYING MORE

ABOUT IN HIS PRESENTATION A BIT LATER IN THE

MEETING.

ON THE OTHER HAND, GOING DOWN TO OUR

YOUNGEST SCIENTISTS, HAD A WONDERFUL EVENT AT USC

HOSTED BY DEAN PULIAFITO, WHICH WAS DEDICATED TO

HIGH SCHOOL STUDENTS DOING SUMMER INTERNSHIPS IN THE

USC STEM CELL LABS.

OUR COLLEAGUE KEVIN MCCORMACK WILL GIVE

MORE CHAPTER AND VERSE ON THAT, BUT JUST SUFFICE IT

TO SAY IT WAS WONDERFUL TO SEE THE YOUNGEST MEMBERS

OF THE STEM CELL RESEARCH COMMUNITY INTERACTION.

AND AS I MENTIONED IN MY BLOG, THE FUTURE IS IN GOOD

HANDS IF THESE STUDENTS ARE ANY INDICATION.

ALSO, MOVING A BIT FURTHER UP THE

EDUCATION CONTINUUM, WE HAD OUR BRIDGES MEETING,

WHICH, AGAIN, WILL BE DISCUSSED IN MORE DETAIL A BIT

LATER. BUT THAT, OF COURSE, FEATURED OUR WONDERFUL

BRIDGES STUDENTS FROM COLLEGES WHO ARE PARTICIPATING

WITH HOST INSTITUTIONS AND DOING STEM CELL WORK.

AND THEY, AS ALWAYS, WHEN YOU TALK TO THEM AND VIEW

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POSTERS AND ALL THAT SORT OF THING, KNOCK YOUR SOCKS

OFF AS TO THE HIGH LEVEL OF TALENT THAT WE HAVE AND

THAT WE'VE HAD THE PRIVILEGE OF FUNDING.

A NUMBER OF OTHER MEETINGS THAT WERE OVER

THE COURSE OF THE LAST FEW WEEKS. DR. FEIGAL HAS

LED THE LATEST IN THE CONTINUING SERIES OF CLINICAL

DEVELOPMENT ADVISORY PANEL MEETINGS WHEREIN WE GET

PROGRESS REPORTS ON DISEASE TEAM WORK, WHICH IS

ALWAYS INTERESTING AND REALLY HIGHLY SUBSTANTIVE

BOTH FOR THOSE LISTENING AND FOR THOSE PRESENTING

THROUGH THE TREMENDOUS COMMENTARY AND

RECOMMENDATIONS PROVIDED BY THE PANEL SO ABLY DRAWN

TOGETHER BY DR. FEIGAL.

WE HAD, OF COURSE, THE EARLY TRANSLATION

IV GRANTS WORKING GROUP AND A COUPLE OF MEETINGS

THAT ELONA PUT TOGETHER WHICH WERE MOST INSTRUCTIVE

ON THE PRESENTATIONS BY A NUMBER OF OUR GRANTEES TO

A BUNCH OF VENTURE CAPITALISTS AND TO SORT OF SEE

THE INTERACTION THERE, AS WELL AS A MEETING ON SORT

OF TOOLS AND TECHNOLOGIES, WHERE ARE THE HURDLES IN

STEM CELL RESEARCH THESE DAYS, A VERY ROBUST

DISCUSSION BY A NUMBER OF HIGHLY QUALIFIED EXPERTS.

SO THERE'S BEEN A LOT OF ACTIVITY, AND IT,

AS ALWAYS, CONTINUES TO SHOW THE BREADTH OF WORK

BEING DONE BY EVERYBODY AT CIRM AND THOSE THAT WE'RE

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FORTUNATE ENOUGH TO BE ABLE TO FUND.

THE LAST THING I'D LIKE TO MENTION, JUST

AS A HOUSEKEEPING ITEM, OUR DECEMBER MEETING IS

GOING TO BE, WHICH IS IN LOS ANGELES AS IT WAS LAST

YEAR, IS NOW A TWO-DAY AFFAIR AS WE WILL BE HEARING

REPORTS AND VOTING ON THE DISEASE TEAM III AWARDS.

AND SO IF EVERYBODY COULD NOTE ON THEIR CALENDAR

THAT IT'S DECEMBER 11TH AND 12TH, AND THAT, AS LAST

YEAR, WE NOW HOPE TO HAVE AN ANNUAL TRADITION.

PLEASE NOTE THE EVENING OF DECEMBER 11TH WILL BE A

HOLIDAY PARTY AT THE CHAIR'S HOUSE IN LOS ANGELES.

SO WITH THAT, THAT CONCLUDES THE

CHAIRMAN'S REPORT. ONE THING I WILL SAY BEFORE

TURNING IT OVER TO DR. TROUNSON, WHEN WE BREAK FOR

LUNCH, AS A SPECIAL TOUCH FOR DUANE, WE ARE GOING TO

TAKE A PICTURE OF THE BOARD AND STAFF WHICH WE'RE

GOING TO SEND TO DUANE. AND SO IF EVERYBODY, BEFORE

WE GO OUT THERE, AND I'LL MENTION THIS AGAIN, FIGURE

OUT WHERE WE'RE GOING TO CONVENE TO DO THAT. UP

HERE? IT'S GOING TO BE A LITTLE TIGHT. WE WANT TO

HAVE, OF COURSE, DUANE'S NAME TAG PROMINENTLY

FEATURED. SO WE'LL TALK ABOUT THAT AT THE TIME.

ANYWAY, SO THAT CONCLUDES THE CHAIR'S

REPORT. NOW ON TO THE PRESIDENT'S REPORT. DR.

TROUNSON.

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MS. SAMUELSON: MR. CHAIRMAN, CAN WE

ACCESS THROUGH THE WEB SITE OR SOMETHING THE REPORTS

OR SLIDE PRESENTATIONS OR WHATEVER FROM THE DISEASE

TEAMS? AND THEN THERE WAS ANOTHER -- ONE OF THE

OTHER MEETINGS YOU WENT TO THAT SOUNDED VERY

INTERESTING. I WAS JUST WONDERING IF WE CAN SEE THE

MATERIALS THAT ARE AVAILABLE?

CHAIRMAN THOMAS: DR. FEIGAL.

DR. FEIGAL: I'D BE HAPPY TO GO OVER IT,

AND WE GIVE YOU UPDATES AT THE BOARD. BUT THESE ARE

CONFIDENTIAL AND PROPRIETARY INFORMATION THAT'S

PRESENTED. BUT I'D BE HAPPY TO TALK WITH YOU OR THE

BOARD AT THE APPROPRIATE TIME.

MS. SAMUELSON: WELL, I'D REALLY LIKE TO

SEE THE MATERIALS. AND AS A BOARD MEMBER WITH A

FIDUCIARY DUTY, I THINK IT'S INCUMBENT ON US TO LOOK

AT THEM. AND, OF COURSE, HONORING THE CONFIDENCE.

CHAIRMAN THOMAS: JOAN, PERHAPS YOU COULD

HAVE A SIDEBAR DISCUSSION WITH DR. FEIGAL.

MS. SAMUELSON: OF COURSE.

DR. FEIGAL: YEAH. I'D BE MORE THAN HAPPY

TO HAVE A CONVERSATION WITH YOU OFF-LINE. THANK

YOU.

MS. SAMUELSON: THANKS.

CHAIRMAN THOMAS: THANK YOU. DR.

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TROUNSON.

DR. TROUNSON: THANKS VERY MUCH, CHAIR.

AND JUST TO ECHO YOUR SENTIMENTS FOR DUANE, IT WAS A

SHOCK FOR ALL OF US TO HEAR ABOUT THE TERRIBLE

ACCIDENT. AND, YOU KNOW, WE REACH OUT TO RENEE AND

DUANE'S OTHER FAMILY. I HOPE THAT THEY'RE ABLE TO

GET THROUGH THIS REASONABLY QUICKLY AND HE'S ABLE TO

RECOVER FULL HEALTH IN SHORT AS POSSIBLE TIME. JUST

TO SEE THE EMPTY SEAT IS QUITE DISTURBING REALLY

KNOWING A GOOD FRIEND IS IN QUITE A BIT OF TROUBLE

AT THE MOMENT.

WITH THAT, LET'S TALK A LITTLE BIT MORE

ABOUT SCIENCE. I HAVEN'T BEEN -- I WASN'T HERE AT

THE LAST BOARD MEETING BECAUSE I WAS IN GERMANY AT

AN INSTITUTE REVIEW. BUT THERE ARE A NUMBER OF VERY

IMPORTANT PAPERS THAT HAVE COME THROUGH JUST

RECENTLY. AND THIS ONE IN PARTICULAR IS

VASCULARIZATION AND FUNCTION OF HUMAN LIVER FROM

IPS-DERIVED ORGAN BUD TRANSPLANT.

SO WHAT THEY'VE DONE HERE, AS SHOWN IN THE

TOP PART OF THE LINE, IS TO TAKE HUMAN-INDUCED

PLURIPOTENTIAL STEM CELLS AND THEN CO-CULTURE THOSE

CELLS WITH TWO OTHER CELL TYPES. THEY'RE THE HUMAN

MESENCHYMAL STEM CELLS, THE CELLS THAT ARE IN THE

BONE MARROW, THE BONE MARROW ORIGINS, STROMAL CELLS,

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THE BONE MARROW ORIGIN. AND ALSO HUMAN UMBILICAL

VEIN ENDOTHELIAL CELLS, WHICH ARE THE CELLS THAT GO

TO FORM UP THE BLOOD VESSELS.

SO THIS COMBINATION OF CULTURE WAS ABLE

TO, ACTUALLY IN A THREE-DIMENSIONAL CULTURE SYSTEM,

WAS ABLE TO SHOW -- ON THE BOTTOM LINE THERE ARE

PICTURES -- GET THE CELLS TO COALESCE AND MOVE

TOGETHER AND ACTUALLY FORM WHAT THEY CALL ORGAN

BUDS, LIVER BUDS. AND THESE BUDS HAVE THE SYSTEM OF

THE LIVER CELLS INTACT IN THERE.

AND WHEN THEY TRANSPLANTED THOSE INTO

SUITABLE MICE, IMMUNE-SUPPRESSED MICE, THEN THESE

HUMAN LIVERS BEGAN TO FUNCTION AND, IMPORTANTLY,

THEY'RE ABLE TO VASCULARIZE VERY QUICKLY. WITHIN 48

HOURS THE LIVER HAS TO BE QUICKLY VASCULARIZED. AND

THESE LIVERS WERE ABLE TO DEAL WITH HUMAN-SPECIFIC

DRUG METABOLISM, WHICH IS A REALLY IMPORTANT POINT,

AND RESCUED LETHAL LIVER FAILURE IN THIS MOUSE

MODEL -- IN A MOUSE MODEL.

SO THIS IS AN ORGAN, IF YOU LIKE, THAT'S

BEEN NOW DEVELOPED. AND THIS GROUP IN YOKOHAMA

CITY -- SO THERE'S NOW BEEN A NUMBER OF PAPERS IN

THIS AREA WHERE YOU TAKE THE STEM CELL DERIVATIVES

AND YOU CULTURE THEM WITH OTHER CELLS. IT'S THE

INSTRUCTIONS FROM THESE OTHER CELLS WHICH ENABLE THE

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STEM CELLS TO TAKE ON THEIR PROPER ROLE OR FUNCTION,

MATURE, AND GET UP INTO PROPER FUNCTION.

SO WE HAVEN'T HAD A LOT OF THESE STUDIES

IN THE WORK THAT WE'VE BEEN SUPPORTING, SO I'M VERY

KEEN TO SEE MORE CO-CULTURE WORK TO MATURE SOME OF

THE CELLS THROUGH TO FUNCTIONAL TYPE. LIVER HAS

BEEN ONE OF THE AREAS WHERE IT'S REALLY BEEN A

PROBLEM. AND TO GET A MATURE CELL, YOU WILL BE

AWARE ALSO HEMATOPOIETIC STEM CELLS THAT WILL

ENGRAFT IN THE BONE MARROW CAN'T BE DEVELOPED UNLESS

YOU GO INTO SOME SORT OF CO-CULTURED SYSTEM. AND

THEY'VE BEEN ABLE TO SHOW IN REPRODUCTIVE TISSUES

THAT IF YOU USE SOMATIC CELLS FROM FETAL OVARY, YOU

CAN INSTRUCT THE DEVELOPMENT OF EGGS AND EMBRYOS AND

BABY MICE ALL FROM STEM CELLS.

I THINK WE'VE GOT A TECHNICAL FAILURE

GOING ON HERE. SO MAYBE I'LL LOOK OVER MARIA'S

SHOULDER WHILE THIS SORT OF GETS ITS MIND BACK

TOGETHER AGAIN.

SO THE SECOND PAPER I WANTED TO TALK

ABOUT, YOU CAN'T SEE CLEARLY, BUT I CAN BEAUTIFULLY

HERE OVER MARIA'S SHOULDER. IT'S FROM THE GROUP

BING REN AND JOE ECKER AT THE LUDWIG & SALK

INSTITUTES IN LA JOLLA. IT'S AN ABSOLUTELY FABULOUS

PAPER. IT'S ONE OF THOSE PAPERS LIKE SOME OF THOSE

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THAT THEY'VE PRODUCED BEFORE WHICH ARE HUGELY

CREDITED IN THE LITERATURE.

SO THIS IS AN EPIGENETIC ANALYSIS OF

MULTILINEAGE DIFFERENTIATION OF HUMAN EMBRYONIC STEM

CELLS. HOW DO CELLS DIFFERENTIATE IN DIFFERENT

LINEAGES BECAUSE IT'S ALL ABOUT HOW YOU CONTROL THE

GENES THAT ARE BEING EXPRESSED. SO THIS EPIGENETICS

IS A CRITICAL COMPONENT.

THEY'VE STARTED TO WORK THROUGH THIS IN A

VERY EFFECTIVE WAY. SO THEY STUDIED THE REAL KEYS

TO THE CONTROL OF GENE EXPRESSION. THAT'S DNA

METHYLATION, CHROMATIN REMODELING AND TRANSCRIPTOME,

JUST TO WORK OUT HOW ALL OF THESE CELLS MAKE THESE

TRANSITIONS TO WHAT WE CALL MESOENDODERM. MESODERM

FORMS MUSCLE. AND MESOENDODERM ALSO FORM ENDODERM,

WHICH IS THE PRIMARY ORGANS OF THE INTERNAL ORGANS.

ALSO LOOKED AT THE NEURAL PROGENITORS WHICH GO TO

FORM THE NEURONS AND GLIA, TROPHOBLAST-LIKE CELLS,

WHICH ARE PART OF THE PLACENTAL FAMILY, AND THEN

MESENCHYMAL STEM CELLS, WHICH ARE THE STROMAL CELLS

THAT GO TO FORM IN MOST ORGANS.

SO THEY LOOKED AT ALL OF THESE, AND THEY

FIGURED IT THROUGH WITH A HUGE AMOUNT OF DATA THAT

PROMOTERS ARE ACTIVE. THE REAL CRITICAL

OBSERVATIONS ARE PUT DOWN HERE. THE PROMOTERS ON

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THESE GENES ARE ACTIVE IN EARLY DEVELOPMENTAL STAGES

TEND TO BE THOSE THAT ARE RICH IN THE DINUCLEOTIDES,

CG, WHICH ARE KNOWN AS CPG ISLANDS, AND THEY MAINLY

ENGAGE A METHYLASE ENZYME THAT IS ACTIVE UPON

SILENCING. SO THAT'S THE WAY THEY SILENCE THE GENES

IN EARLY DEVELOPMENT.

FOR THOSE THAT ARE PREFERENTIALLY

EXPRESSED AT LATER STAGES, THEY'RE OFTEN CG POOR AS

A DIFFERENCE TO THE OTHER, THE GENES THAT COME ON

EARLY AND PRIMARILY EMPLOY METHYLATION PROCESS TO

REPRESS.

AND THEN THESE EARLY DEVELOPMENTAL

REGULATORS ARE OFTEN LOCATED IN LARGE GENOMIC

DOMAINS THAT ARE GENERALLY DEVOID OF DNA METHYLATION

IN MOST LINEAGES, WHICH IS TERMED -- THEY CALL THESE

DNA METHYLATION VALLEYS. SO WE'RE NOW STARTING TO

WORK OUT THE WHOLE PRO FORMA ABOUT HOW CELLS MOVE IN

THESE DIFFERENT LINEAGES. AND THESE WILL HELP

SCIENTISTS FIGURE OUT WHAT TO DO WITH BOTH IPS CELLS

AND EMBRYONIC STEM CELLS AND BE ABLE TO DIRECT THE

CELLS TO GO TO THE KIND OF LINEAGES THAT ARE

INTERESTS OF THOSE GROUPS IN THEIR PARTICULAR

RESEARCH. SO IT WILL ATTRACT A LOT OF ATTENTION.

IT'S A VERY DETAILED, BUT INTERESTING PAPER.

I HAD TO TALK ABOUT BRIEFLY AT LEAST THE

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HUMAN EMBRYONIC STEM CELLS WHICH WERE DERIVED FOR

THE FIRST TIME BY SOMATIC NUCLEAR TRANSFER BY

SHOUKHRAT MITALIPOV'S LAB IN OREGON, WHICH WAS

PUBLISHED IN CELL IN JUNE. AND THEY WERE REASONABLY

EFFICIENT IN DERIVING SOMATIC CELL NUCLEAR TRANSFER.

I'LL JUST GIVE YOU A FEW OF THE FIGURES ON THAT.

IT'S BEEN TRIED FOR A LONG TIME TO GET

THIS TO WORK IN THE HUMAN. IT'S WORKED IN THE

MOUSE. IT'S WORKED IN THE MONKEY. SO MANY OF US

THOUGHT, WELL, IT'S KIND OF VERY STRANGE THAT IT

DOESN'T WORK IN A HUMAN. AND NOW IT HAS WORKED.

AND THIS IS THE GROUP THAT MADE IT WORK, SHOWED IT

COULD WORK IN THE MONKEY IN THE FIRST PLACE.

SO THEY HAD A REASONABLY HIGH RATE OF

SUCCESS IN THEIR TECHNOLOGY, AND I THINK THIS IS THE

KEY. THESE ARE VERY EXPERIENCED MICROMANIPULATING

EMBRYOLOGISTS, AND THEY'RE ABLE TO GET HIGH RATES OF

ENUCLEATION, FUSION, AND GET THE EMBRYOS TO DEVELOP

THROUGH THE VARIOUS STAGES AT PRETTY HIGH RATES.

AND TO END UP WITH -- THEY FORMED FOUR EMBRYONIC

STEM CELL LINES BY NUCLEAR TRANSFER WHICH WAS FROM

THE 60 STARTING OOCYTES, WHICH IS ABOUT 7 PERCENT,

WHICH IS A RELATIVELY HIGH FIGURE. AND THEN THEY

REPRODUCED IT IN A PATIENT WITH LEIGH SYNDROME WHERE

THEY USED 20 OOCYTES FROM TWO DONORS AND PRODUCED 35

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PERCENT OF THOSE AS THE BLASTOCYST, THE MORE

ADVANCED EMBRYOS, AND TWO OF THEM WENT ON TO MAKE

STEM CELLS.

SO IF YOU LOOK AT THIS CARTOON, THE TOP

LINE SHOWS WHAT HAPPENS IN NORMAL DEVELOPMENT. THE

SPERM ENTERS AN EGG, FORMS A ZYGOTE, GOES ON, IF

IT'S TRANSFERRED TO THE UTERUS, WILL FORM A BABY.

OR IF YOU TAKE OUT THE INNER CELL MASS CELLS, YOU

CAN FORM EMBRYONIC STEM CELLS. SO THE SECOND LINE

IS WHAT THEY DID. SO YOU TAKE -- YOU REMOVE THE

NUCLEUS FROM THE EGG. SO NOW THE EGG NUCLEUS IS

GONE SO THAT THE GENOMIC COMPONENT FOR THE EGG IS

GONE. YOU INSERT BY ELECTRICAL FUSION A NUCLEUS

FROM YOUR ADULT CELL, AND THAT WILL DEVELOP TO A

BLASTOCYST, AND YOU CAN MAKE EMBRYONIC STEM CELLS

FROM THAT.

THE IMPORTANT OTHER BIT ON THE BOTTOM LINE

IS THAT YOU CAN USE THIS TECHNIQUE TO HELP PATIENTS

WHO HAVE MITOCHONDRIAL DISEASE. MITOCHONDRIAL

DISEASE IS INCREDIBLY SEVERE IN PEOPLE WHO HAVE THAT

AND THE MAJORITY OF MITOCHONDRIAL MUTATION, AND THAT

WILL BE THE METABOLIC DISORDER OR REALLY SEVERE

ABNORMALITY, GENETIC ABNORMALITY. WELL, YOU CAN

TAKE A CELL FROM THOSE PATIENTS, INSERT THAT INTO AN

EGG, AND YOU CAN FORM, IF YOU HAVE APPROVAL TO DO

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THAT, YOU COULD FORM A CHILD THAT DOESN'T HAVE THAT

MITOCHONDRIAL GENETIC DISORDER, OR YOU CAN MAKE

EMBRYONIC STEM CELLS WHICH YOU MIGHT USE TO HELP

THOSE POOR PATIENTS WITH THOSE KIND OF DISEASES.

SO THERE'S NOW A MODEL FOR LOOKING REALLY

INTENTLY AT MITOCHONDRIAL DISORDERS. SO THERE'S A

FAIRLY SIGNIFICANT PAPER AND ATTRACTED A LOT OF

DISCUSSION IN THE SCIENTIFIC PRESS AND IN LAY PRESS.

THERE'S ALSO, I THOUGHT, A VERY

INTERESTING PAPER FROM THE UNIVERSITY OF MASS

MEDICAL SCHOOL AND THE COMPANY SANGAMO THAT WE

SUPPORT, ONE OF OUR GRANTEES, LOOKING AT DOWN'S

SYNDROME. DOWN'S SYNDROME IS A TRISOME. IT'S THREE

COPIES OF CHROMOSOME 21. IT'S A VERY COMMON

DISORDER UNFORTUNATELY, AND IT'S MORE PREVALENT IN

PARENTS THAT ARE OVER THE AGE OF 37, 37 AND OLDER,

AND IT LEADS TO PHENOTYPES WHICH ARE VERY VARIABLE,

BUT CAN BE VERY SEVERE.

SO WHAT THEY'VE DONE HERE, WHAT NORMALLY

HAPPENS IN DEVELOPMENT IS THAT ONE OF THE -- IN THE

FEMALE ONE OF THE TWO X CHROMOSOMES HAS TO BE

INACTIVATED. SO RANDOMLY THE XIST GENE INACTIVATES.

IT COATS ONE OF THE X CHROMOSOMES AND INACTIVATES

THEM. SO IN EVERY FEMALE, ONE OF THE EGG'S X

CHROMOSOMES BECOMES INACTIVE. IN THE MALE YOU DON'T

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WANT TO DO THAT BECAUSE YOU'VE ONLY GOT ONE X

CHROMOSOME, SO IT DOESN'T HAPPEN IN MALES. SO IT'S

THE XIST GENE THAT DOES IT.

SO WHAT THEY'VE DONE IS TAILOR A TARGET

USING THE ZINC FINGER NUCLEASE TECHNOLOGY OF SANGAMO

WHERE THEY TARGETED THE XIST GENE INTO A GENE THAT'S

ON CHROMOSOME 21. AND WHEN THEY DID THAT, THIS

ENTERED THE CELLS OF THE DOWN'S SYNDROME CELLS AND

IT COATED ONE OF THE CHROMOSOME 21 CELLS AND TURNED

IT OFF. TURNED IT INTO WHAT WE CALL A BARR BODY, SO

IT WAS NONFUNCTIONAL. SO YOU DROP THE GENE DOSAGE

FROM THREE TO TWO, WHICH BRINGS YOU BACK TO THE

NORMAL STATE.

IT'S A VERY IMPORTANT OBSERVATION. IT'S A

GREAT MODEL FOR SCIENTISTS NOW TO WORK OFF THAT TO

LOOK AT THE CONDITIONS AND THE PHENOTYPES OF DOWN'S

SYNDROME AND PARTICULARLY THOSE SEVERE TYPES OF

PHENOTYPE IN DOWN'S SYNDROME, BUT IT'S ALSO POSSIBLE

IN THE LONGER TERM WAY OF LOOKING TO SEE IF WE CAN

CONTROL THIS EXTRA GENE DOSAGE IN THESE KIDS THAT

ARE BORN WITH DOWN'S SYNDROME, WHICH WOULD BE A

REALLY, REALLY IMPORTANT DEVELOPMENT IN TIME. SO

I'M NOT TRYING TO PREDICT THAT THAT'S GOING TO

HAPPEN SOON, BUT THE MODELS ARE GOING TO BE SET UP

FOR THAT TO BE EXPLORED. SO I THOUGHT IT WAS A

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REALLY GREAT PIECE OF WORK, AND I THOUGHT I SHOULD

BRING THAT TO YOUR ATTENTION.

SO MOVING OFF THOSE NOW, BECAUSE THERE

WERE MANY OTHER PAPERS, BUT I THOUGHT THAT'S ENOUGH.

REALLY QUITE IMPRESSIVE GROUP OF PAPERS. BUT JUST

TO NOTIFY YOU OF THE AWARD THAT WAS MADE TO MARIUS

WERNIG, WHO'S AN M.D. PH.D. FROM STANFORD,

ABSOLUTELY BRILLIANT YOUNG SCIENTIST, AND WAS GIVEN

THE OUTSTANDING YOUNG INVESTIGATOR AWARD AT THE

INTERNATIONAL SOCIETY FOR STEM CELL RESEARCH. HE'S,

OF COURSE, ONE OF OUR GRANTEES, AND WE'RE INCREDIBLY

PROUD OF MARIUS. HE'S A PHENOMENAL YOUNG SCIENTIST,

AND HE'S CLEARLY GOING TO BE ONE OF THOSE PEOPLE

THAT WILL SET THE WORLD ON FIRE WITH ALL THE WORK

THAT HE'S DOING.

HE'S INVOLVED WITH THE DISEASE TEAM THAT'S

LOOKING AT THE SKIN DISORDER, THE PRIMARY SKIN

DISORDER, EPIDERMOLYSIS BULLOSA. HE'S ALSO THE

SCIENTIST WHO'S BEEN WORKING ON DIRECT

DIFFERENTIATION OR CHANGING CELLS INTO NEURONS OR

NEURAL PROGENITORS WITH TRANSCRIPTION FACTORS, BUT

DOING THAT IN A VERY SHORT-CIRCUITED WAY. AND HIS

WORK IS ATTRACTING A LOT OF INTEREST AROUND THE

WORLD.

WE HAVE A NEW APPOINTMENT THAT WILL BE

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JOINING US END OF JULY AND IS GOING TO BE WORKING

WITH ME AS AN EXECUTIVE ASSISTANT, WHICH MEANS WE'RE

GOING TO LOSE CANDACE. CANDACE IS GOING TO LEAVE US

AT THE START OF JULY. SHE'S GOING TO GO TO GRADUATE

SCHOOL IN EDINBURGH TO BE AN AUTHOR. SO SHE'S GOING

TO WRITE STORIES ABOUT YOU GUYS. I KNOW WHO SHE'S

GOING TO WRITE ABOUT. AS AN AUTHOR YOU USE THE

BASIS OF WHAT YOU LEARN IN LIFE TO WRITE THE

STORIES. SO LOOK -- KEEP AN EYE ON THE LITERATURE

THAT COMES FROM CANDACE. AND WE REALLY DO WISH HER

THE BEST GOING TO EDINBURGH.

YOU'LL NEED TO RUG UP THERE. SO WE'RE

WISHING HER FROM THE STAFF ALL THE BEST IN MOVING

ON. AND WE'RE GOING TO WELCOME MANDA AT THE END OF

THIS MONTH.

THE RFA PROGRAMS, JUST TO KEY YOU IN,

ALPHA CLINICS IS A CONCEPT AT THIS MEETING. TOOLS

AND TECHNOLOGIES III CONCEPT AT THIS MEETING.

RESEARCH LEADERSHIP EXTENSION CONCEPT AT THIS

MEETING. SO A LOT OF CONCEPTS HERE FOR THIS

PARTICULAR MEETING.

STRATEGIC PARTNERSHIP III, THE RFA WILL BE

POSTED THIS MONTH, HAS BEEN POSTED THIS MONTH.

EARLY TRANSLATIONAL IV, THERE'S AN ICOC FUNDING

DECISION IN AUGUST. DISEASE TEAM III, THE GRANTS

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WORKING GROUP REVIEW OF APPLICATIONS WILL BE

SEPTEMBER. WE EXPECT TO BRING IT TO THE BOARD IN

DECEMBER, AS JON SAID. BASIC BIOLOGY V, THE GRANTS

WORKING GROUP REVIEW WILL BE PROBABLY IN OCTOBER.

AND THE GENOMICS RE-REVIEW OF THE GENOMICS RFA WILL

BE DONE IN NOVEMBER. SO A LOT OF WORK JUST COMING

UP IN THE NEXT FEW MONTHS FOR ALL OF US.

JUST TO FILL YOU IN ON THE RESEARCH

LEADERSHIP AWARDS, JUST TO KEY THEM THROUGH, SANFORD

BURNHAM IS APPOINTED. UC SANTA BARBARA APPOINTED,

USC APPOINTED. PARKINSON'S INSTITUTE DECLINED THEIR

NOMINEE. CEDARS-SINAI HAVE APPOINTED THEIR PERSON

AS HAVE UC SAN DIEGO. SO THAT'S GREAT. STANFORD IS

COMPLETING THEIR TASK OF BRINGING THEIR PERSON ON,

AND THE UC SANTA CRUZ IS IN PROGRESS. GLADSTONE

INSTITUTE IS IN NEGOTIATION. WE EXPECT THAT WILL

PROBABLY BE OKAY, BUT IT'S IN NEGOTIATION. AND

FINALLY UC SAN FRANCISCO, UNFORTUNATELY WE JUST

HEARD YESTERDAY THAT THAT WAS DECLINED. SO JUST TO

FILL YOU IN ON THOSE LEADERSHIP AWARDS. SO WE'RE

PROBABLY GOING TO END UP WITH EIGHT, MAYBE SEVEN,

BUT I THINK THAT'S THE LIST FOR THE PRESENT TIME.

AND, OF COURSE, THOSE INSTITUTES THAT

HAVEN'T HAD AN AWARD HAVE BEEN IN PARTICULAR TALKING

TO ME AND HOPING THAT THEY'LL GET ANOTHER CHANCE.

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SO WE'LL BE BRINGING A CONCEPT TO YOU TO DISCUSS

THAT WITH YOU TODAY.

EXTERNAL INNOVATION RFA WE'RE RELEASING.

THIS IS THE ONE THAT REALLY CONNECTS US TO THOSE

ABSOLUTELY BRILLIANT THINGS THAT ARE HAPPENING

OUTSIDE CALIFORNIA, TRIES TO CONNECT THAT WITH SOME

OF OUR CALIFORNIA RESEARCHERS. SO TO BE ABLE --

THOSE CALIFORNIA INVESTIGATORS TO COLLABORATE WITH

UNIQUELY PROMISING RESEARCH. THERE'S REALLY

IMPORTANT WORK THAT'S GOING ON THAT WE HAVEN'T GOT

IN CALIFORNIA. BECAUSE THERE'S SO MUCH MOVEMENT IN

THE FIELD, THIS HAPPENS. CALIFORNIA IS THE LEADER

CLEARLY, BUT AT TIMES OTHER RESEARCHERS GET OUT AND

DO SOME ABSOLUTELY PHENOMENAL WORK, AND WE'D LIKE TO

CONNECT THAT TO CALIFORNIA AT TIMES.

SO IT TARGETS WORLD-CLASS OPPORTUNITIES

THAT WE CAN'T REACH THROUGH OTHER RFA'S. AND THEY

HAVE TO BE TRULY EXCEPTIONAL. WE'RE EXPECTING ONE

OR TWO AT THE MOST A YEAR. AWARDS ARE UP TO THREE

YEARS, 500,000 A YEAR, AND, OF COURSE, IS SUBJECT TO

GRANTS WORKING GROUP REVIEW AND ICOC APPROVAL AS YOU

AGREED. SO IAN WILL PROBABLY MENTION THAT AGAIN

WHEN HE TALKS ABOUT COLLABORATIVE FUNDING PARTNERS.

AND IF YOU WANT TO DISCUSS ANY OF THIS WITH HIM, I'M

SURE HE'LL BE HAPPY TO TALK ABOUT IT.

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UPCOMING MEETINGS, THE MEETINGS THAT WE

JUST HAD, THE BRIDGES TRAINEE MEETING WAS PHENOMENAL

AS USUAL. THOSE PEOPLE, THOSE YOUNG PEOPLE ARE JUST

FANTASTIC. YOU KNOW, THE STORIES THAT THEY HAVE ARE

REALLY INSPIRING. I WAS TALKING TO A YOUNG WOMAN

WHO'S A SINGLE MOTHER WITH THREE KIDS, AND THE KIDS

HAVE MOVED ON FAR ENOUGH FOR HER TO REENGAGE IN

SCIENCE, AND SHE WAS INTO IT IN A REALLY EMPHATIC

WAY. SHE WAS A BRIDGES STUDENT. SHE WAS WANTING TO

GO ON. HOPED TO DO A PH.D. THROUGH NURSING AND WAS

REALLY, REALLY DRIVEN. AND YOU HEAR MANY DIFFERENT

STORIES LIKE THIS. ALL OF US GOT THESE WONDERFUL

STORIES AT THIS MEETING OF THESE YOUNG PEOPLE WHO

ARE SO COMPLETE IN THEIR AMBITIONS TO BE PART OF

WHAT WE'RE DOING. IT IS PHENOMENAL, AND SO ANY

CHANCE YOU GET TO MEET THESE PEOPLE, IT'S REALLY

INSPIRING. IT REALLY IS.

SO IT'S ONE OF THE PROGRAMS I'M REALLY,

REALLY PROUD OF. THE STAFF ARE AND I KNOW YOU ARE.

AND TO GET THEM TOGETHER AND PRODUCING THEIR POSTERS

AND TALKING TO THEM, THEY'RE LIKE PH.D. STUDENTS OR

POST DOCS. THEY'RE SO EMPHATIC. I DIDN'T WANT TO

LET YOU GO AND I WANT TO ASK YOU, QUIZ YOU ABOUT

WHAT DO YOU THINK THAT WAS RIGHT. IT WAS FANTASTIC.

THOSE ARE WONDERFUL YOUNG PEOPLE.

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HAD A CREATIVITY POSTER DAY, AND THAT WAS

FANTASTIC. THIS IS YOUNG PEOPLE COMING FROM HIGH

SCHOOL. AND, AGAIN, THESE KIDS ARE LIKE MY PH.D.'S.

THERE'S PROBABLY MORE ENTHUSIASM IN THESE HIGH

SCHOOL STUDENTS IN COMING IN AND WORKING WITH THE

TEAMS. THEY ARE GOING TO CREATE CAREERS, AND I HOPE

THAT THEY WILL BE IN SCIENCE, AND I HOPE THAT SOME

OF THEM WILL SORT OF COME BACK AND SORT OF BE WITH

US OR BE PART OF WHAT WE'RE DOING IN THE FUTURE.

THEY ARE JUST PHENOMENAL. THESE YOUNG PEOPLE

EMBRACE THE LAB. THE LOVED IT.

THEY THOUGHT THAT THEY WERE GOING TO BE

DOING ALL THE WASHING UP AND ALL THE DIRTY CHORES.

NO, THEY WEREN'T. THEY WERE ENGAGED AND THEY WERE

ACTUALLY INTO THE LAB. THEY WERE ACTUALLY DOING

ASSAYS AND RUNNING GELS AND STUFF. OH, IT WAS

FANTASTIC. IT REALLY DOES TURN THOSE YOUNG PEOPLE

ON. SO I THINK THEY'RE GREAT PROGRAMS.

WE HAD THE NIH REGENERATIVE MEDICINE

INTERACTIONS WITH INDUSTRY AS WELL IN AUGUST.

THERE'S AN IPS INITIATIVE START-UP MEETING

THAT WE BROUGHT ALL OF THE IPS DERIVERS AND THE

TEAMS THAT WERE COLLECTING THE SAMPLES AND THE BANK

TOGETHER. WE HAD A GREAT DAY. WE HAD LOTS OF

DEBATE ABOUT HOW WE SHOULD DO THOSE THINGS, AND I

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THINK WE CAME TO REALLY GOOD CONSENSUS VIEWS ON HOW

TO DO THE WHOLE THING.

AND MIKE YAFFE, WHO'S HERE, IS GOING TO BE

TAKING OVER MANAGEMENT OF THAT PROGRAM. IT'S A

REALLY IMPORTANT PROGRAM FOR US TO MAKE SURE THAT

THE PEOPLE USE THIS BANK TO THE MAXIMUM. SO MIKE IS

GOING IN TO MANAGE THAT, AND WE THANK HIM VERY MUCH

FOR STEPPING UP TO THAT. AND WE WANT TO THANK UTA

FOR ALL OF THE BACKGROUND WORK THAT SHE'S DONE ON

GETTING IT TO THAT POINT.

SO ATTRACTING A LOT OF INTEREST, THAT

BANK, FROM ALL AROUND THE WORLD ABOUT WE HAVE NOW

REALLY TAKEN THE FRONT LINE IN THE IPS CELL AREA,

WHICH I THINK IS WONDERFUL.

THERE'S AN NINDS MEETING ON IPS CELLS MAY

30 TO THE 1ST OF JUNE. THE ISSCR, AS JON SAID, JUNE

12TH TO THE 15TH, SO WE WERE REALLY BUSY AT MEETINGS

THROUGH THAT TIME.

THERE WAS A REIMBURSEMENT STRATEGIES

WEBINAR ON JUNE 20TH, SO WE'RE STARTING TO LOOK AT

ABOUT HOW WE SHOULD UNDERSTAND HOW TO FRAME OUR WORK

TO LOOK INTO REIMBURSEMENT. AND THERE WAS A CIRM VC

FIRST LOOK ON JUNE THE 24TH. SO NIEL LITTMAN, WHO

HEADS UP OUR BUSINESS DEVELOPMENT GROUP UNDER ELONA,

WAS THE ONE WHO REALLY PUT A LOT OF ENERGY IN

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GETTING THOSE PEOPLE TOGETHER. AND THAT WORKED

REALLY, REALLY WELL AND HAVE TAKEN THOSE CONCLUSIONS

FROM THAT MEETING AND ARE PUTTING INTO THEIR PROCESS

AND BRINGING IT FORWARD. SO I THINK THAT KIND OF

THING IS DOING A LOT OF REALLY GOOD THINGS FOR THE

REGENERATIVE MEDICINE, BUT ALSO PARTICULARLY OUR

INTEREST IN THE AREA.

THERE WAS A TOOLS AND TECHNOLOGIES R & D

ROUNDTABLE ON THE 25TH. SO IT FOLLOWED ON LOOKING

FOR WHAT WERE THE THINGS THAT WERE NEEDED

PARTICULARLY IN THE TRANSLATIONAL AREAS, AND WE CAME

UP WITH SOME VERY DEFINITIVE VIEWS ON THAT.

AND THERE WAS A NATIONAL EYE INSTITUTE NIH

WORKSHOP MOVING TOWARDS CELL-BASED IND FOR DISEASES.

THAT WAS JUNE 24TH TO THE 25TH, AND ELLEN AND

COLLEAGUES WERE ATTENDING THAT.

WE HAD THE HOUSE OF LORDS SELECT COMMITTEE

ON SCIENCE AND TECHNOLOGY, AND I ASKED MARIA TO LET

YOU KNOW THAT THAT WAS PUBLISHED. IT WAS A TERRIFIC

REPORT. AND THANK EVERYBODY FOR PUTTING IN THE

EFFORTS, ALL OF THE CALIFORNIA SCIENTISTS AND

BUSINESS PEOPLE WHO CAME TO MEET WITH THEM. IT WAS

A LOOK AT OBSTACLES TO DEVELOPMENT OF REGENERATIVE

MEDICINE IN THE UK. THEY VISITED US DECEMBER 3D TO

THE 5TH. THOSE WERE THE LORDS FROM THE HOUSE. AND

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THEY'RE VERY IMPRESSIVE PEOPLE, I CAN TELL YOU, WHO

CAME.

WE HAD TEN PANELS OF 30 PARTICIPANTS. AND

LORD KREBS IS THE CHAIR. HERE'S A QUOTE FROM HIM.

"WE LOOKED AROUND THE WORLD TO SEE WHERE THINGS ARE

BEING DONE WELL, AND WE THOUGHT THAT THE PLACE TO GO

IS CIRM." AND THERE ARE NUMEROUS QUOTES IN THE

REPORT THAT WENT TO THE LORDS AND IS A REPORT TO THE

LORDS AND OTHERS, THE HOUSE OF REPRESENTATIVES IN

THE UK, WITH LOTS OF QUOTES ON THE KIND OF THINGS

THAT WE DO REALLY VERY WELL. SO IT WAS NICE TO HAVE

THAT GROUP OF PEOPLE OPINE ON THE KIND OF THINGS

THAT WE DO. SO I'LL LEAVE THAT PARTICULAR THING

THERE.

AND I THINK WE'RE GOING TO TREAT THIS

SEPARATELY, MARIA, THE STRATEGIC GOALS. ARE THERE

ANY PARTICULAR QUESTIONS, AND WE'LL MOVE ON TO THE

NEXT SUBJECTS BEFORE WE DO ANYTHING MORE? ANY

QUESTIONS?

MS. SAMUELSON: I HAVE A COMMENT ON THE

FAILURE OF THE PI GRANT. AND WE CAN DO IT WHEN

WE'RE REVIEWING THE EXTENSION OF THAT PROGRAM, MR.

CHAIRMAN, OR NOW.

CHAIRMAN THOMAS: LET'S WAIT TILL THE

EXTENSION DISCUSSION, JOAN.

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MS. SAMUELSON: OKAY. THANKS.

DR. TROUNSON: SO LET ME INVITE CHILA UP

TO TALK ON THE FINANCIAL REPORT TO YOU.

MS. SILVA-MARTIN: THANK YOU, DR.

TROUNSON. GOOD MORNING, MR. CHAIR, MEMBERS OF THE

BOARD, AND THE PUBLIC. TODAY I'M GOING TO PROVIDE

YOU WITH A BRIEF FINANCIAL UPDATE. AS YOU ARE

PROBABLY AWARE, OUR FINANCIAL FISCAL -- OUR FISCAL

YEAR IS FROM JULY 1 THROUGH JUNE 30TH. SO WE ARE

JUST FINISHING UP THE '12-'13 FISCAL YEAR. WE ARE

CURRENTLY WORKING ON THE YEAR-END PROCESS.

OUR FINANCIAL REPORTS ARE DUE TO THE STATE

CONTROLLER'S OFFICE ON AUGUST 20TH, AND WE'RE ON

TRACK TO MEET THAT DEADLINE.

SO BASED ON THIS TIMELINE, WE WILL BE

PRESENTING TO YOU THE FULL YEAR FINANCIAL STATEMENTS

AT THE NEXT BOARD MEETING. WHAT I CAN SAY AT THIS

POINT REGARDING THE '12-'13 FISCAL YEAR EXPENDITURES

IS, AS YOU RECALL ON SEVERAL OTHER OCCASIONS, I HAVE

PRESENTED TO YOU PROJECTIONS FOR THE '12-'13 FISCAL

YEAR, AND WE'RE PRETTY MUCH ON TRACK WITH THOSE

PROJECTIONS. I DON'T ANTICIPATE ANY MAJOR

DEVIATIONS FROM THOSE NUMBERS.

AS SOON AS WE COMPLETE THE YEAR-END

FINANCIAL PROCESS, WE'RE GOING TO GO RIGHT INTO THE

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ANNUAL FISCAL FINANCIAL AUDIT. WE'VE ALREADY MADE

CONTACT WITH THE AUDITORS, AND AT THIS TIME THE PLAN

IS FOR THE AUDITORS TO COME IN AT THE END OF AUGUST

AND COMPLETE THE FIRST DRAFT OF THE REPORT BY

OCTOBER 1ST, AND THEN HAVE THE FINAL REPORT TO THE

STATE CONTROLLER'S OFFICE SOMEWHERE AROUND OCTOBER

15TH.

AND THEN LASTLY, I JUST WANT TO TOUCH UPON

THE FINANCIAL DATABASE. AND ALEX CAMPE WILL

ACTUALLY BE PRESENTING ON THIS LATER IN MORE DETAIL.

BUT AS YOU MAY RECALL, AS PART OF THE PERFORMANCE

AUDIT, ONE OF THE RECOMMENDATIONS WAS THAT WE

CONSIDER SOME TYPE OF A FINANCIAL DATABASE. SO WE

DID PROCURE GREAT PLAINS, AND WE ARE CURRENTLY

WORKING WITH THE VENDORS TO UPLOAD OUR '13-'14

FINANCIAL DATA INTO THE SYSTEM. SO THE GOAL REALLY

OF THE SOFTWARE IS TO ASSIST US IN ELIMINATING SOME

REDUNDANCIES THAT WE CURRENTLY HAVE AND REALLY

PROVIDING US WITH GREATER FINANCIAL REPORTING

CAPABILITIES.

SO NOW JUST MOVING ON TO A VERY BRIEF AND

HIGH LEVEL OVERVIEW OF OUR FINANCIAL STATUS AS OF

JUNE 30TH, 2013. SO OUR GRANT DISBURSEMENTS FOR THE

'12-'13 FISCAL YEAR WERE JUST UNDER $200 MILLION AS

COMPARED TO THE PRIOR FISCAL YEAR '11-'12 WHICH WE

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DISBURSED ABOUT $203 MILLION.

NOW, WE CONTINUE TO RECEIVE FUNDING,

MONTHLY DISBURSEMENTS, THROUGH COMMERCIAL PAPER; AND

AS A RESULT, WE MAINTAIN A VERY HEALTHY CASH

RESERVE. OUR AVAILABLE CASH AS OF JUNE 30TH WAS $68

MILLION, WHICH IS ABOUT A $4.4 MILLION INCREASE FROM

WHAT WE HAD IN APRIL, WHICH IS WHAT I REPORTED AT

THE MAY ICOC BOARD MEETING. ALL OF THIS REALLY TO

SAY IS THAT WE'RE IN VERY GOOD SHAPE TO CONTINUE

OPERATIONS INTO THE COMING MONTHS.

AND THIS REALLY CONCLUDES MY FINANCIAL

UPDATE. ARE THERE ANY QUESTIONS? GREAT. THANK

YOU.

CHAIRMAN THOMAS: THANK YOU. AND, ALAN,

THANK YOU, AS ALWAYS, FOR YOUR INTERESTING

PRESIDENTIAL REPORT. AND, AS USUAL, YOU HAVE ADDED

TO OUR GLOSSARY OF AUSTRALIAN VERNACULAR. I BELIEVE

TODAY'S NEW EXPRESSION WAS RUGGING UP. DID I HEAR

THAT CORRECTLY? YES. DR. OLSON.

DR. OLSON: GOOD MORNING. WHAT I'D LIKE

TO DO NOW IS, AS WE AGREED, GIVE THE BOARD AN UPDATE

ON THE RFA FUNDING STATUS THAT WE DO EVERY TIME WE

ARE GOING TO BRING CONCEPT PROPOSALS TO YOU.

SO THIS IS ACTUALLY AN UPDATE FROM WHAT

WAS PRESENTED TO YOU AT THE LAST MEETING IN MAY. SO

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I JUST WANT TO REMIND YOU THAT THE 2.77 BILLION

AVAILABLE FOR RESEARCH FUNDING WE CATEGORIZE IN A

COUPLE OF DIFFERENT WAYS. AND I'M GOING TO GO INTO

A LITTLE BIT MORE DETAIL JUST BECAUSE WE HAVE SO

MANY NEW MEMBERS HERE TODAY. SO I BEG THE

INDULGENCE OF THOSE OF YOU WHO ARE VERY FAMILIAR

WITH THIS. BUT --

MS. SAMUELSON: EXCUSE ME, PAT. DO WE

HAVE PAPER ON THIS? I'M SORRY.

DR. OLSON: I BELIEVE YOU DO. WE WILL

SEND IT TO YOU.

MS. SAMUELSON: THANKS.

DR. OLSON: THE AWARDED CATEGORY ARE THOSE

FUNDS THAT HAVE BEEN APPROVED BY THE ICOC FOR

SPECIFIC PROJECTS. AND ESSENTIALLY THE $1.67

BILLION THAT YOU SEE THERE IS COMPARABLE TO WHAT YOU

SAW LAST MONTH. YOU HAVEN'T APPROVED ANYTHING IN

MAY OR AT THIS MEETING.

THE CONCEPT APPROVED CATEGORY IS WHERE THE

ICOC HAS AGREED TO ALLOCATE A GIVEN AMOUNT OF FUNDS

TO BE AVAILABLE FOR A GIVEN REQUEST FOR

APPLICATIONS, FOR A GIVEN FUNDING PROGRAM.

THIS CATEGORY HAS INCREASED SINCE LAST

TIME, AND WE'LL GO IN MORE DETAIL. RECALL THAT WHAT

I DO IS I MAKE THE ASSUMPTION THAT ALL THE CONCEPT

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PROPOSALS BEING BROUGHT TO YOU TODAY WILL BE

APPROVED. IF THAT'S NOT THE CASE, YOU WILL SEE A

CHANGE NEXT TIME WE PRESENT, BUT CURRENTLY THAT

CATEGORY IS AT $491 MILLION.

THE FUTURE FUNDING ARE OBVIOUSLY THE

REMAINING RESEARCH FUNDS.

THE NEXT SLIDE JUST SORT OF SHOWS THAT

YOUR FUTURE FUNDING CAN BE FURTHER BROKEN DOWN INTO

WHERE IT'S BEEN ALLOCATED ACCORDING TO THE FUNDING

PLAN THAT WAS PRESENTED TO YOU EARLY LAST YEAR AND

APPROVED BY YOU. AND THE SO-CALLED UNALLOCATED

CATEGORY ARE THOSE CASES WHEN THERE'S AN APPROVED

CONCEPT PROPOSAL. FOR EXAMPLE, I'LL JUST USE ONE

EXAMPLE, STRATEGIC PARTNERSHIP I. YOU APPROVED IN

CONCEPT $30 MILLION FOR THAT RFA. IN POINT OF FACT,

WE ONLY -- YOU AWARDED ONLY $20 MILLION IN AWARDS.

SO THE $10 MILLION GOES INTO THAT POT.

WHAT I WANT TO DO NOW IS JUST GIVE YOU A

LITTLE BIT MORE DETAIL ON THE FUNDING ALLOCATION.

AND AGAIN, JUST ESPECIALLY FOR THOSE NEW MEMBERS, WE

FURTHER -- WHEN WE MAKE AWARDS, WE PUT THEM INTO

CERTAIN CATEGORIES. SO A FACILITIES CATEGORY ARE

FACILITIES/CORE RESOURCES ARE THINGS LIKE THE MAJOR

FACILITIES. WHEN WE FUNDED MAJOR FACILITIES, CORE

RESOURCES IS SOMETHING LIKE THE IPSC PROGRAM WHICH

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YOU'VE HEARD ABOUT, AND THE ALPHA CLINIC WHICH WILL

BE COMING TO YOU TODAY. THOSE KINDS OF PROGRAMS,

DEPENDING ON WHERE THEY ARE, EITHER AWARDED, FUTURE,

OR CONCEPT, WOULD BE IN THAT CATEGORY.

TRAINING/CAREER DEVELOPMENT, YOU'VE HEARD

ABOUT OUR RESEARCH LEADERSHIP PROGRAM. YOU'VE HEARD

ABOUT OUR CREATIVITY PROGRAM. YOU'VE HEARD ABOUT

THE BRIDGES PROGRAM. ALL OF THOSE FALL INTO THAT

PARTICULAR CATEGORY.

BASIC RESEARCH IS REASONABLY

SELF-EXPLANATORY. OUR GENOMICS PROGRAM, OUR BASIC

BIOLOGY PROGRAM FALL INTO THAT CATEGORY.

TRANSLATIONAL RESEARCH CATEGORY INCLUDES

OUR EARLY TRANSLATION RESEARCH PROGRAMS, OUR TOOLS

AND TECHNOLOGIES AWARDS PROGRAM.

THE DEVELOPMENT CATEGORY INCLUDES

ESSENTIALLY OUR IND ENABLING, OUR PRECLINICAL

DEVELOPMENT PROGRAMS, AND OUR CLINICAL DEVELOPMENT

PROGRAMS, ALL THOSE PROGRAMS THAT FALL UNDER

REGULATION. SO THAT'S WHAT'S IN THAT CATEGORY.

SO HAVING SAID THAT, I JUST WANT TO NOTE

THAT, AGAIN, AS I SAID BEFORE, THIS CATEGORY HASN'T

CHANGED REALLY SINCE THE LAST TIME YOU SAW IT. AND

AS YOU CAN SEE, THE DISTRIBUTION OF THE FUNDING IN

THAT CATEGORY RANGES FROM 14 PERCENT TO 25 PERCENT.

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THE CONCEPT APPROVED CATEGORY, THIS IS, AS

NOTED BEFORE, THIS INCLUDES THE CONCEPTS BEING

BROUGHT FORWARD TO YOU TODAY. SO WHAT'S NEW SINCE

WE LAST DISCUSSED IS IN THE TRAINING/CAREER

DEVELOPMENT. WE'RE PROPOSING AN EXTENSION TO THE

RESEARCH LEADERSHIP PROGRAM, AND YOU WILL HEAR ABOUT

THAT LATER FROM DR. YAFFE.

IN THE TRANSLATION CATEGORY, WE'RE

PROPOSING THE THIRD ITERATION OF OUR TOOLS AND

TECHNOLOGIES PROGRAM, AND YOU WILL HEAR ABOUT THAT

LATER TODAY FROM DR. LILA COLLINS.

THE OTHER THING THAT'S CHANGED IS IN THE

FACILITIES/CORE RESOURCES CATEGORY, AND WE ARE

BRINGING FORTH THE ALPHA CLINICS PROGRAM TODAY TO

CREATE A CORE RESOURCE TO MAKE CALIFORNIA A CENTER

FOR CLINICAL DEVELOPMENT IN STEM CELL-BASED

THERAPIES. AND AGAIN, YOU WILL HEAR ABOUT THAT

LATER TODAY FROM DRS. DEWITT AND MILLAN.

SO THE OTHER CATEGORIES, I'LL JUST REMIND

YOU WE HAVE OUTSTANDING CONCEPT PROPOSALS AND

THEY'RE IN THE REVIEW PROCESS FOR BASIC BIOLOGY AND

THE BASIC PROGRAM FOR DISEASE TEAM III AND SP III IN

THE DEVELOPMENT CATEGORY, AND FOR ET IV IN THE

TRANSLATION CATEGORY. SO THAT PRETTY MUCH COMPRISES

THAT.

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FUTURE FUNDING JUST HIGHLIGHTS THE

ALLOCATION, AND THIS BASICALLY REPRESENTS, AGAIN, AS

WE NOTED IN THE STRATEGIC PLAN, THE FACT THAT IT

COSTS A LOT OF MONEY TO DEVELOP THERAPIES TO ACHIEVE

CLINICAL PROOF OF CONCEPT, WHICH IS ONE OF OUR KEY

GOALS AND PART OF OUR MISSION. SO THIS JUST

OUTLINES THIS CATEGORY, HOW THE FUNDING HAS BEEN AT

LEAST CURRENTLY PLANNED FOR ALLOCATION IN THIS

CATEGORY.

SO FINALLY, I JUST HAVE PROVIDED

ESSENTIALLY THE INFORMATION THAT HAS BEEN PROVIDED

IN TABLE FORM BEFORE, BUT IN PERHAPS MORE DETAIL

HERE SO THAT YOU CAN SEE HOW AT LEAST THE FUNDING

HAS BEEN ALLOCATED INTO AWARDED PROGRAM, HOW IT

CURRENTLY IS IN THE CONCEPT APPROVED, AND HOW THE

FUTURE IS GOING. SO HOW ESSENTIALLY THE 2.78

BILLION WILL BE USED.

AND I JUST WANT TO MAKE THE POINT THAT,

AGAIN, THAT THIS CONTINUES. WE ARE IMPLEMENTING THE

FUNDING STRATEGY APPROVED BY THIS BOARD. WE ARE

USING EXCESS UNALLOCATED FUNDS THAT ARE CONSISTENT

WITH THAT STRATEGY, AND THAT THERE IS CURRENTLY OR

THERE WILL BE, ASSUMING APPROVAL OF ALL CONCEPTS,

CLOSE TO 600 MILLION AVAILABLE FOR FUTURE FUNDING.

SO I'M HAPPY TO ANSWER ANY QUESTIONS.

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CHAIRMAN THOMAS: MR. SHEEHY.

MR. SHEEHY: THANKS FOR THE PRESENTATION,

DR. OLSON. SO, YOU KNOW, THIS THING WILL SEGUE INTO

OUR STRATEGIC PLAN UPDATE AS WELL. LAST FALL WE

PRESENTED TWO DIFFERENT SCENARIOS FOR FUNDING. SO

ARE WE OPERATING UNDER SCENARIO 1 OR SCENARIO 2?

DR. OLSON: AT THE MOMENT WE ARE OPERATING

UNDER SCENARIO 1. AS WE SAID AT THIS TIME THAT THIS

WOULD BE SUBJECT TO REVISITATION, AND I THINK THAT'S

SOMETHING THAT'S BEING PLANNED FOR POSSIBLY LATER

THIS YEAR.

MR. SHEEHY: OKAY. SO IN SCENARIO 1 WE

BASICALLY ZEROED OUT TRAINING AND DEVELOPMENT

FUNDING.

DR. OLSON: THAT'S RIGHT. WE HAD ACTUALLY

VERY LIMITED. WE DID NOT DO TRAINING AGAIN. AND,

AGAIN, THAT WAS GOING TO BE A DISCUSSION POINT.

MR. SHEEHY: THAT WOULD BE TRAINING AND

BRIDGES, RIGHT?

DR. OLSON: THAT'S CORRECT.

MR. SHEEHY: AND AGAIN, WHY I HAVE THE

QUESTION, I GUESS I THINK AS A BOARD APPROVES SOME

OF THESE OR DOES NOT APPROVE SOME OF THESE

INITIATIVES TODAY, ARE WE NOT MAKING DECISIONS --

SO, FOR INSTANCE, IF I VOTE FOR RESEARCH LEADERSHIP,

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AM I NOT SAYING THAT I'M NOT GOING TO VOTE FOR AN

EXTENSION OF BRIDGES? THAT I'M NOT GOING TO VOTE

FOR EXTENSION OF TRAINING?

DR. OLSON: I DON'T THINK YOU'RE SAYING

THAT. I THINK WHAT YOU ARE SAYING IS THAT WHAT YOU

MIGHT WANT TO DO IS YOU MIGHT WANT TO REVISE THE

ALLOCATION FOR FUTURE FUNDING AT SOME POINT. AND I

WOULD SUGGEST THAT I KNOW THAT WE WERE TARGETING

PERHAPS RAISING THIS DISCUSSION NEAR THE END OF THIS

YEAR.

MR. SHEEHY: BECAUSE I GUESS ONCE WE

APPROVE ALL THIS STUFF, YOU CAN'T REALLY GO BACK AND

UNDO IT.

DR. OLSON: WELL, LET ME ALSO REMIND YOU

THAT ALTHOUGH WE HAVE, WHAT DID I SAY, 491 IN THE

CONCEPT APPROVED CATEGORY, WE'VE ALL HAD EXPERIENCE

WITH THE FACT THAT NOT ALL CONCEPTS GET FULLY

AWARDED. NOW, CURRENTLY I DROP THAT MONEY BACK INTO

THE CATEGORY IN WHICH IT WAS ORIGINALLY DONE. SO

OBVIOUSLY I THINK IT IS WORTHWHILE HAVING THE

DISCUSSION ABOUT ARE WE STILL HAPPY WITH THE

ALLOCATION. AND I THINK THAT DISCUSSION WILL BECOME

IMPORTANT LATER THIS YEAR.

MR. SHEEHY: BUT IS IT UNFAIR AS A BOARD

MEMBER AT THIS POINT IN TIME TO THINK ABOUT AN

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EXTENSION OF RESEARCH LEADERSHIP BEING IN DIRECT

COMPETITION WITH AN EXTENSION OF BRIDGES OR

TRAINING, AND/OR TRAINING? I MEAN IT SEEMS TO ME

THAT AS A BOARD MEMBER THAT SHOULD BE THE FRAMEWORK

FROM WHICH I'M LOOKING AT IT BECAUSE WE ARE KIND OF

THINKING ABOUT CERTAIN POTS.

AND I LOOK AT EVEN FUTURE SCENARIO 2,

WHICH WAS THE MOST OPTIMISTIC FOR TRAINING AND

DEVELOPMENT, AND WE ONLY TALKED ABOUT $60 MILLION

UNDER THAT. AND IF WE DO ANOTHER 25 MILLION INTO

RESEARCH LEADERSHIP TRAINING OR BRIDGES, SEEMS LIKE

IT'S GOING TO START TO HAVE TO COME OUT OF

DEVELOPMENT OR TRANSLATIONAL OR BASIC. IN OTHER

WORDS, WE'RE APPROVING A LOT OF STUFF TODAY, AND

THAT MEANS THAT A LOT OF THINGS THAT WE MAY WANT TO

DO A YEAR DOWN THE ROAD, BECAUSE TRAINING IS GOING

TO END, I THINK, IN THE NEXT YEAR. I THINK BRIDGES

IS GOING TO END IN THE NEXT --

DR. OLSON: THOSE DECISIONS DON'T NEED TO

BE MADE NEXT YEAR.

MR. SHEEHY: WELL, WHEN DO THOSE RFA'S

END?

DR. OLSON: I'VE GONE THROUGH AND LOOKED

AT THIS. AND AS I SAY, THAT'S WHY I THINK WE DO

NEED TO HAVE A DISCUSSION AT THE END OF THIS YEAR

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THAT MAINLY HAS TO DO WITH THE SHARED LABS. WE NEED

TO HAVE A DISCUSSION ON TRAINING. I THINK ALL OF

THIS COMES INTO A DISCUSSION ON ARE WE HAPPY WITH

THE ALLOCATIONS. I THINK WE WERE THINKING ABOUT THE

END OF THIS YEAR. I WOULD NOTE THAT EVEN IN THE

FUTURE FUNDING CATEGORY, EVEN IF WE APPROVE THE

RESEARCH LEADERSHIP, THAT THERE IS STILL 21 MILLION.

THESE CATEGORIES ARE NOT FIXED IN STONE. THIS IS

WHAT WE TALKED ABOUT ON A CERTAIN PLAN. SO, YOU

KNOW, WE CAN CHANGE IT.

MR. SHEEHY: I KNOW. WE'RE MAKING

DECISIONS TODAY THAT WILL HAVE AN IMPACT. WE MAY

HAVE THIS DISCUSSION AT THE END OF THE YEAR, BUT WE

WILL HAVE ALREADY APPROVED --

DR. OLSON: RIGHT.

MR. SHEEHY: -- SEVERAL MILLION DOLLARS.

AND $21 MILLION ALLOCATED MIGHT COVER BRIDGES, BUT

THAT LEAVES NO MONEY FOR TRAINING. AND I GUESS IF

THE BOARD DOESN'T WANT TO CONTINUE OUR TRAINING

PROGRAM -- I THINK THAT'S ONE OF THE THINGS WE MAY

BE DECIDING TODAY -- IF WE DECIDE TO CONTINUE

RESEARCH LEADERSHIP. WE MAY BE DECIDING TODAY THAT

WE DON'T WANT TO CONTINUE BRIDGES IF WE DECIDE TO

FUND RESEARCH LEADERSHIP. DON'T YOU THINK AS A

BOARD MEMBER THAT WOULD BE A RESPONSIBLE WAY IN

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WHICH TO APPROACH THIS DECISION?

DR. OLSON: I THINK WHAT I'M SAYING TO YOU

IS YOU HAVE THE OPTION OF SHIFTING THE ALLOCATION

AMONGST THE CATEGORIES. THAT IS WHAT I'M SAYING TO

YOU. AND THAT IS, YOU KNOW, SOMETHING THAT I DO

THINK YOU'LL WANT TO LOOK AT AT SOME POINT.

MR. SHEEHY: AGAIN, JUST NOT TO BE TOO

PROCESS ORIENTED, BUT WE DID TALK ABOUT LAST FALL

TWO DIFFERENT FUNDING SCENARIOS.

DR. OLSON: RIGHT.

MR. SHEEHY: SO IF THAT EXERCISE HAS NO

IMPORT OR DOESN'T DIRECT US TO KIND OF THINK ABOUT

THINGS IN A WAY GOING FORWARD, ARE WE JUST

APPROVING -- I GUESS I GET CONFUSED BECAUSE IF THAT

WAS NOT IN SOME WAY DIRECTIVE, THEN WE'RE JUST KIND

OF APPROVING THINGS KIND OF LIKE SERENDIPITOUSLY.

DR. OLSON: WHAT I COULD DO IS THE NEXT

TIME I DID THIS, I COULD MAKE AVAILABLE WHAT THIS

WOULD LOOK LIKE UNDER SCENARIO 2.

MR. SHEEHY: YOU KNOW, I'M NOT TRYING TO

PUT YOU ON THE --

DR. OLSON: I UNDERSTAND.

MR. SHEEHY: -- SPOT.

DR. OLSON: I APPRECIATE THE CONCERN.

MR. SHEEHY: BECAUSE I THINK YOU AND I ARE

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PROBABLY ON THE SAME PAGE, THAT WE NEED TO MAKE SOME

CHOICES BECAUSE WE DON'T NEED TO BE SITTING HERE AT

THE END OF THE DAY WITH ALL THE MONEY ALLOCATED AND

SAY, GOD, I WISH WE HAD MONEY LEFT OVER FOR THIS OR

HAD MONEY LEFT OVER.

AS MORE TO MY FELLOW BOARD MEMBERS, AS WE

ARE APPROVING THINGS, WE NEED TO THINK THAT THERE

ARE NOW COSTS INVOLVED. THERE ARE OTHER THINGS THAT

WE WON'T BE ABLE TO DO IF WE DO THINGS TODAY, AND

THAT NEEDS TO BE PART OF HOW WE APPROACH SOME OF

THESE THINGS. SO THAT WAS MY POINT. I'M SORRY.

YOU'RE UNDER THE GUN ON THIS AND IT'S PROBABLY NOT

FAIR.

DR. OLSON: NO. I MEAN I GUESS I

BASICALLY AM JUST TRYING TO KEEP THE BOARD AND

EVERYBODY AWARE OF MORE OR LESS WHERE WE ARE. I

THINK THAT THE OPTION HAS ALWAYS BEEN THAT OF

CHANGING HOW MONEY IS ALLOCATED IN THE FUTURE. I

MEAN YOU ALL HAVE THE STRATEGIC PLAN. YOU ALL

UNDERSTAND THE THINKING THAT WENT INTO IT. I THINK

YOU ALL RECOGNIZE THAT THE CONCEPT FUNDING OF $491

MILLION, THE LIKELIHOOD OF THAT ALL GETTING AWARDED,

I WOULD SAY, IS NEXT TO ZERO. THAT MONEY WILL GO

BACK INTO THIS FUTURE FUNDING POT, AND YOU HAVE SOME

SAY.

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CHAIRMAN THOMAS: DR. TROUNSON.

DR. TROUNSON: SO IT'S IMPORTANT TO BE

INFORMED ABOUT WHAT REMAINS AND WHAT WE AGREED TO AT

THE LAST AGREEMENT ABOUT THE CONSTRUCT. WHAT WE'RE

GOING TO BE DOING IN AUGUST IS TO GET SOME INPUT

FROM THE SCIENTIFIC ADVISORY BOARD. AND THAT MIGHT

COME BACK WITH SEVERAL OR SOME SEVERAL

RECOMMENDATIONS. THEIR REPORT WILL COME BACK TO THE

BOARD WITH COMMENTS FROM US. I THINK THAT'S THE

TIME TO SORT OF RELOOK BECAUSE WE SORT OF GOT TO BE

LOOKING AT WHETHER THERE'S 600 -- AROUND ABOUT 600

MILLION THAT'S STILL LEFT TO BE ALLOCATED. I THINK

WHAT HAPPENS IS THAT YOU HAVE TO HAVE TAKEN A LOOK

AT DIFFERENT TIMES AND MAKE THOSE DECISIONS; BUT

CERTAINLY AS YOU AGREE TO FUND SOMETHING, IT WILL

CLEARLY BE LESS MONEY IN THE TOTAL POT AT THE END

UNLESS WE GET REFUNDED, OF COURSE.

SO I WAS GOING TO BRING THE

RECOMMENDATIONS OF THE SCIENTIFIC ADVISORY BOARD,

WHICH WE FOCUS ON WHAT THEY THINK WE SHOULD BE

HAVING OUR FOCUS, AND IT MAY OR MAY NOT BE

SUPPORTIVE COMPLETELY OF OUR STRATEGIC PLAN, BUT IT

WILL BE A RECOMMENDATION WE'LL BRING TO THE BOARD

FOR FURTHER DISCUSSIONS ABOUT HOW WE ORIENT

OURSELVES. AND IT'S VERY CLEARLY THE CASE. WE MET

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WITH THE STEM CELL LEADERSHIP, THAT THEY'RE VERY

SUPPORTIVE OF THESE TRAINING PROGRAMS AND HAVING

THEM TO CONTINUE, BUT THEN THEY'RE SUPPORTIVE OF ALL

THE PROGRAMS. THAT'S PART OF THE PROBLEM. EVERYONE

IS SUPPORTIVE OF ALL OF THE PROGRAMS. SO IT'S NOT

THAT THERE'S ANY PROGRAM THAT'S NOT SUPPORTED, BUT

CLEARLY THERE'S A STRONG SUPPORT FOR THE TRAINING

PROGRAMS AS WELL AS ALL THE OTHERS THAT WE'RE

ACTUALLY BRINGING FORWARD AT THE MOMENT.

CHAIRMAN THOMAS: DEAN PULIAFITO.

DR. PULIAFITO: SO IF WE APPROVE ALL THE

CONCEPTS TODAY, YOU'RE SAYING THAT WE HAVE $600

MILLION MORE OR LESS, 577, UNALLOCATED?

DR. OLSON: YES.

DR. PULIAFITO: THERE WAS ANOTHER NUMBER

THAT SAID $115 BILLION. THAT WAS ON YOUR SECOND TO

LAST SLIDE. WHAT WAS THAT? 115 MILLION.

DR. OLSON: THAT'S JUST MORE DETAIL

BECAUSE THE SLIDE I PRESENTED HERE, FUTURE, INCLUDES

FUTURE ALLOCATED AND FUTURE UNALLOCATED. I THINK IN

THE THIRD SLIDE I EXPLAIN --

DR. PULIAFITO: SO THIS IS FUTURE

UNALLOCATED?

DR. OLSON: NO. THAT'S BOTH. THAT'S THE

TWO COMBINED.

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DR. PULIAFITO: SO HOW MUCH MONEY DO WE

HAVE LEFT THAT'S UNALLOCATED?

DR. OLSON: 500 -- YOU HAVE 577 MILLION

THAT HAS BEEN ALLOCATED ACCORDING TO A FUNDING

STRATEGY.

DR. PULIAFITO: SO IN WHAT CALENDAR YEAR

ARE WE GOING TO STOP MAKING NEW AWARDS BY THIS MATH?

DR. OLSON: 16/17.

DR. TROUNSON: IT, AGAIN, DEPENDS ON --

DR. PULIAFITO: NOT WHEN WE'RE SPENDING,

BUT SITTING IN THIS ROOM APPROVING THINGS. IS IT

GOING TO GO FOR ANOTHER TWO YEARS?

DR. TROUNSON: 2017. 2017 IS WHEN WE

WOULD PREDICT AT THE CURRENT RATE OF DECISION-MAKING

THAT IN 2017 THAT WE WON'T BE ABLE TO ALLOCATE

FURTHER NEW GRANTS, 2017. MAYBE IT WILL BE A LITTLE

BIT LONGER, 2018, BUT 2017 IS WHAT WE PREDICT.

DR. PULIAFITO: I'D SAY I AGREE WITH JEFF.

I THINK THERE NEEDS TO BE AN EXAMINATION. FIRST OF

ALL, ALL OF US THAT ARE IN THE RESEARCH WORLD KNOW

THAT SUSTAINABILITY IS A BIG QUESTION. AND WE'RE

NOT -- THERE'S NO EVIDENCE THAT THE NIH IS GOING TO

BE SUSTAINING ANYTHING. OKAY. SO ONE OF THE MAIN

FUNCTIONS OF THE BOARD IS TO SET OUT A FUNDING

STRATEGY THAT MAKES SENSE GOING FORWARD.

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YOU KNOW, IT'S EASY TO SAY YES, YES, YES

FOR EVERYTHING. BUT IF WE ONLY HAVE -- WE COMMITTED

2.4 BILLION. WE HAVE 600 MILLION LEFT. WE REALLY

NEED TO LOOK AT HOW WE'RE GOING TO SPEND THAT 600

MILLION.

DR. OLSON: LET ME REMIND THE BOARD THIS

IS A FUNDING STRATEGY THAT WAS AGREED TO BY THE

BOARD. I MEAN JEFF IS CITING ANOTHER SCENARIO, BUT

THAT WAS ROUGHLY $100 MILLION DIFFERENCE. THAT'S

ALL THAT WAS.

DR. PULIAFITO: I WOULD SAY THE FOLLOWING:

TIMES CHANGE.

DR. OLSON: THAT IS CORRECT.

DR. PULIAFITO: TIMES CHANGE; ENVIRONMENT

CHANGES. THOSE OF US WHO ARE IN THE BIOMEDICAL

RESEARCH ARENA KNOW TIMES ARE TOUGH AND ARE NOT

GOING TO GET BETTER SOONER. SO DECISIONS THAT YOU

MAKE ABOUT HOW YOU SPEND THAT $600 MILLION IS REALLY

GOING TO DETERMINE HOW AND WHAT REMAINS OF STEM CELL

RESEARCH IN CALIFORNIA IF THE NIH STAYS THE SAME,

WHICH I ASSUME IS GOING TO BE YES, AND WHETHER OR

NOT WE'RE REFUNDED, WHICH WE CAN MAKE NO ASSUMPTION

ABOUT AT THIS POINT. SO THAT'S JUST A CAUTIONARY

NOTE. TIME FLIES.

DR. TROUNSON: WE AGREED TO BRING YOU THIS

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DATA ON EVERY MEETING SO THAT WE WOULD MAKE THE

POINT. SO THAT'S EXACTLY WHAT WE AGREED TO DO WITH

THE BOARD.

DR. PULIAFITO: THE QUESTION IS ARE WE

EVER GOING TO JUST SIT BACK AND SAY, OKAY, HERE WE

ARE TODAY. WE'VE GOT 577 -- IF WE SAY YES TO

EVERYTHING TODAY, WE'VE GOT 600 LEFT, AND COULD

EVERY MEMBER OF THE BOARD GO AROUND AND SAY, YEAH,

THIS IS WHAT THE STRATEGIC PLAN SAYS WE'RE SUPPOSED

TO SPEND THE 600. I THINK THE ANSWER IS PROBABLY

NOT.

CHAIRMAN THOMAS: THESE ARE POINTS VERY

WELL TAKEN, JEFF AND CARMEN. WE'VE BEEN HAVING

INTERNAL DISCUSSIONS ON THIS PARTICULAR TOPIC AND

FEEL THAT, IN LIGHT OF WHAT WILL BE A NUMBER OF

MONTHS OF IMPLEMENTING THE DIRECTION THE BOARD DID

DECIDE TO GO LAST YEAR, PLUS THE ADVENT AND MEETING

OF THE STRATEGIC ADVISORY BOARD, TO ALAN, ETC., AND

THE FACT THAT AFTER TODAY FOR THE NEXT SIX MONTHS OR

SO I BELIEVE THERE'S ONLY ONE CONCEPT PROPOSAL

THAT'S COMING, DR. OLSON?

DR. OLSON: LET ME THINK. YES. I DON'T

THINK WE'RE GOING TO SEE MUCH MORE BEFORE THE END OF

THE YEAR IN TERMS OF CONCEPT PROPOSALS. THAT IS

CORRECT.

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CHAIRMAN THOMAS: SO THERE'S NOT GOING TO

BE A LOT. SO I THINK WE'LL BE MORE OR LESS WHERE WE

ARE AT THE END OF THE DAY PLUS MAYBE ONE ADDITIONAL

CONCEPT PROPOSAL. AND WE WERE THINKING ABOUT THE

IDEA OF ACTUALLY, AS WE WERE GOING TO DO LAST

JANUARY, OF HAVING A BOARD RETREAT TO DISCUSS THIS

ISSUE CERTAINLY BECAUSE IT IS, YOU'RE RIGHT, TIMES

DO CHANGE, WE NEED TO REVISIT THE STRATEGIC PLAN IN

LIGHT OF ALL THE INPUT THAT HAS COME IN THE INTERIM,

AND TO DISCUSS AS FULLY AS A BOARD AND VET IT AS TO

WHETHER WE WANT TO CONTINUE ALONG THIS PATH, MODIFY,

ETC. DEAN PULIAFITO.

DR. PULIAFITO: EVERY SCIENTIFIC OFFICER

AT AN INSTITUTE AT THE NIH ARE MAKING THESE

DECISIONS. AND DECISIONS ARE MADE USUALLY WE'RE

GOING TO MAXIMIZE THE ABILITY TO FUND INDIVIDUAL

INVESTIGATORS AND KEEP THEM ALIVE. SO THAT'S, OF

COURSE, MY PREJUDICE LOOKING AT ALL THIS. SO I

WOULD LIKE TO BE IN A POSITION OF SUSTAINING THE

STEM CELL INVESTIGATORS IN CALIFORNIA FOR AS LONG AS

WE POSSIBLY CAN. AND WHEN WE LOOK AT THAT, THEN

JUST ABOUT EVERYTHING IS ON THE TABLE, INCLUDING

BRIDGES, TRAINING, ALL THESE THINGS, BECAUSE

THOSE -- AT THE NIH THEY GET RID OF PROGRAM PROJECT

GRANTS, THEY DOWNSIZE CORE FACILITIES, AND FEATURE

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R01S. AND THAT'S GOING ON RIGHT NOW.

CHAIRMAN THOMAS: I HOPE, BY THE WAY, FOR

EVERYBODY'S SAKE, THAT NIH DOES STAY THE SAME AND

DOESN'T GET WORSE GOING FORWARD.

MS. LANSING: I HOPE IT GETS BETTER.

CHAIRMAN THOMAS: SHERRY.

MS. LANSING: YES.

CHAIRMAN THOMAS: YES, THAT WOULD BE

OUTSTANDING. WITH SEQUESTRATION, ETC., CONTINUING

ALONG, NOT PARTICULARLY, BUT ONE COULD CERTAINLY

HOPE. JOAN, DID YOU HAVE A COMMENT?

MS. SAMUELSON: YEAH. I WOULD HOPE THAT

WE COULD, STARTING REALLY TODAY, COME UP WITH SOME

SENSE OF WHAT MATERIALS WE WILL NEED AS THE BOARD TO

BE INFORMED ENOUGH TO MAKE THOSE JUDGMENTS IN THE

UPCOMING -- IN OUR DECISIONS TODAY AND UPCOMING

MEETINGS. AND I'M THINKING ABOUT THE MATERIALS FROM

THE SCIENTIFIC ADVISORY BOARD. THAT'S NOT THE

GRANTS WORKING GROUP, RIGHT?

CHAIRMAN THOMAS: VERY DIFFERENT.

MS. SAMUELSON: AND WE DON'T GET THEIR

MATERIALS, AND I THINK WE NEED TO HAVE THEM IF WE'RE

GOING TO MAKE THESE JUDGMENTS. BECAUSE WHAT WE'RE

SAYING IS NOT ONLY HOW DO WE CHOOSE AMONG THE

PROGRAMS WE'RE ALREADY FAMILIAR WITH, BUT IF WE'RE

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GOING TO DO ANYTHING ELSE. AND AS FAR AS I CAN

TELL, THE FUNDING STRATEGY AVAILABLE TO US RIGHT NOW

DOES NOT PRODUCE ANY CALIFORNIANS WHO GET BETTER

FROM SUFFERING FROM SOME INTRACTABLE DISORDER. AND

THAT MAY SEEM REALLY SIMPLISTIC, BUT THAT IS THE WAY

OUR CONSTITUENCY EVALUATES IT. AND I THINK WE'RE

GOING TO HAVE TO HAVE ANSWERS TO QUESTIONS ABOUT

THAT AND INFORMED, SERIOUS JUDGMENT ABOUT HOW FAR WE

CAN GO, WHAT WE CAN ACCOMPLISH, AND THAT MIGHT BE A

DIFFERENT GOAL FROM SUSTAINING THE SCIENTIFIC ARMY,

IF YOU WILL, WHICH IS A LAUDABLE GOAL, BUT WE MIGHT

HAVE TO DO SOMETHING SOMEWHAT DIFFERENT IF WE'RE

GOING TO ADVANCE RESCUE OF CALIFORNIANS AND PEOPLE

WORLDWIDE WITH ANY KIND OF DILIGENT EFFORT. THAT

MIGHT TAKE A DIFFERENT STRATEGY.

SO I'M HUNGERING TO GET AT SOME OF THESE

MATERIALS I WAS TALKING TO ELLEN ABOUT. AND I THINK

IT'S IMPORTANT THAT WE FOCUS ON THAT.

CHAIRMAN THOMAS: ALAN.

DR. TROUNSON: JUST ONE THING, JOAN. FOUR

OF THE MEMBERS OF THE SAP ARE MEMBERS OF THE GRANTS

WORKING GROUP. WE'VE INCLUDED STU ORKIN, WHO USED

TO BE THE CHAIR OF THE GRANTS WORKING GROUP. SO

THEY'RE PEOPLE WHO KNOW PRETTY WELL.

CHAIRMAN THOMAS: GOOD POINT. THANK YOU.

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MS. SAMUELSON: IT ISN'T A PROGRAMMATIC

VEHICLE BY WHICH WE'RE INTERACTING AND SHARING

INFORMATION AND MAKING DECISIONS. THINGS COME TO US

AND WE HAVEN'T HAD THE BENEFIT OF RECOMMENDATIONS

LIKE WE DO WITH THE GRANTS WORKING GROUP. SO I'M A

LITTLE CONCERNED.

CHAIRMAN THOMAS: OKAY. DR. OLSON, ARE

YOU DOWN TO YOUR LAST SLIDE HERE?

DR. OLSON: I'M FINISHED UNLESS THERE ARE

MORE QUESTIONS.

CHAIRMAN THOMAS: OKAY. THANK YOU. THANK

YOU, MEMBERS OF THE BOARD, FOR ALL YOUR INSIGHT AND

SUGGESTIONS AS ALWAYS. VERY IMPORTANT POINTS.

MARIA, ARE WE GOING TO THIS NEXT?

MS. BONNEVILLE: YEAH. I THINK WE SHOULD

DO THIS.

CHAIRMAN THOMAS: OKAY. SO WE'RE GOING

NEXT INTO ITEM 6, WHICH IS A REVIEW OF HOW WE'VE

DONE ON OUR ONE-YEAR STRATEGIC PLAN GOALS FOR FISCAL

'12-'13. DR. TROUNSON.

DR. TROUNSON: THESE ARE THE STRATEGIC

PLAN GOALS THAT WE HAD FOR OUR ONE-YEAR FOR 2012-13.

AND THEY'VE ALL GOT TICS BESIDE THEM, SO WE'VE

ACTUALLY ACHIEVED ALL THE GOALS THAT WERE SET UP IN

THE STRATEGIC PLAN. SO WE CAN READ THROUGH THEM,

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BUT IT HAD TO INCLUDE AT LEAST TWO PROGRAMS WITH

APPROVED IND FILING, ACHIEVE $50 MILLION IN OUTSIDE

FINANCIAL COMMITMENTS. WE ACTUALLY HAD 62 OR $63

MILLION. SO WE'RE ABOVE THE 50 MILLION ON THAT.

ENSURE THE FUNDING OF POTENTIALLY HIGH

IMPACT PROJECTS. WE PUT THOSE INTO OUR BASIC

PROJECTS, AND SO THEY'RE THERE. AND EDUCATE AND

ENGAGE THE CALIFORNIA COMMUNITY. SO WE RAISED THE

NUMBER OF MONTHLY ONLINE ENGAGEMENTS FROM 70,000 TO

A HUNDRED THOUSAND. SO THE COMMUNICATIONS GROUP

HAVE DONE VERY WELL THERE.

AND WE'RE ALSO BEGINNING TO OPTIMIZE OUR

WORKFORCE TO MEET THE CHANGING PRIORITIES WITHIN OUR

6-PERCENT CEILING. SO WE ACTUALLY ACHIEVED ALL OF

THOSE GOALS.

SO WHAT WE DID WAS TO SET UP NINE GOALS

FOR THE NEXT 12 MONTHS. SO I WANTED TO BRING THEM

TO YOU SO THAT YOU COULD FOCUS ON THAT. SO WE'VE

BEEN WORKING INTERNALLY TO GET AGREEMENT ON ALL

THESE. SO REMEMBER THERE ARE FIVE-YEAR GOALS SET

INTO THE STRATEGIC PLAN. SO THIS IS THE SECOND YEAR

OF THOSE FIVE YEARS.

SO CIRM PORTFOLIO SHOULD INCLUDE AT LEAST

THREE TO FIVE PROGRAMS ACTIVELY ENROLLING PATIENTS

ON STEM CELL-BASED CLINICAL TRIALS, THREE TO FIVE IN

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THIS NEXT 12 MONTHS.

SECONDLY, TO INITIATE FIVE TO TEN

POTENTIALLY HIGH IMPACT PROJECTS THAT COULD LEAD TO

TRANSFORMING THE FIELD THAT ARE A RESULT OF OUR

MODIFYING PRIORITIES IN THE RFA'S. SO WE HAVE TO BE

ABLE TO SHOW YOU THAT WE'LL HAVE DONE THAT, SOME

REAL IMPACT IN PARTICULARLY OUR BASIC SCIENCE AND

OUR TOOLS AND TECHNOLOGIES AND WHERE ELSE WE CAN

REALLY FIND THESE.

INITIATE KEY IPS CELL AND GENOMIC PROGRAMS

TO FURTHER SOLIDIFY CIRM'S GLOBAL LEADERSHIP IN STEM

CELL RESEARCH. SO WE INTEND TO DO THAT.

IF YOU AGREE, WE'LL INITIATE THE

DEVELOPMENT OF ALPHA CLINIC NETWORKS IN CALIFORNIA

THIS YEAR.

THE OTHER FOUR, COMPLETE A WHITE PAPER,

WHICH WHEN I WAS REVIEWED A LITTLE MORE THAN 12

MONTHS AGO I THINK NOW, I SUGGESTED WE REALLY NEEDED

A WHITE PAPER FOR AN IN-DEPTH ANALYSIS AND

RECOMMENDATION FOR A PUBLIC/PRIVATE FUNDING MODEL

THAT WILL ENHANCE THE TRANSLATIONAL PART OF THE CIRM

PROGRAM. THIS, I THINK, IS SOMETHING THAT THE BOARD

NEEDS TO THINK ABOUT. SO I WANTED TO BRING A PAPER

OF OPTIONS FORWARD FOR THE BOARD BECAUSE THERE ARE

AROUND ABOUT 80 TRANSLATIONAL PROJECTS. AND IF WE

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DON'T HAVE A SUBSTANTIAL AMOUNT OF FUNDING OVER THE

NEXT FIVE TO EIGHT OR NINE YEARS, MANY OF THOSE WILL

GO AGROUND BECAUSE THERE WON'T BE FUNDING FOR THEM

TO CONTINUE.

SO I WAS TRYING TO FIND A WAY THAT WE

MIGHT BE ABLE TO ATTRACT PRIVATE FUNDING TO JOIN US

IN PUSHING THOSE TRANSLATIONAL PROJECTS FORWARD.

AND I DIDN'T WANT TO REALLY BE IN A POSITION TO

THINK THAT WHEN WE FINISH OUR FUNDING, THAT A LOT OF

THOSE PROJECTS WERE GOING TO SORT OF CEASE BECAUSE

OF THIS SO-CALLED VALLEY OF DEATH OR THE AREA WHERE

IT IS HARDEST TO GET FUNDING. SO WE'RE GOING TO

BRING SOMETHING TO YOU AND GIVE IT TO YOU AND SAY

HERE'S A POSSIBILITY THAT WE MIGHT BE ABLE TO

CONSIDER.

WE WANT TO LEVERAGE 60 MILLION PLUS IN NEW

OUTSIDE FINANCIAL COMMITMENTS FOR CIRM. SO RAISE

THAT ANOTHER $10 MILLION FROM LAST YEAR.

DOUBLE THE NUMBER OF STATEWIDE PUBLIC

SPEAKING ENGAGEMENTS AND INCREASE THE NUMBER OF

MONTHLY IMPRESSIONS ON OUR SOCIAL MEDIA SITES BY 10

PERCENT, TO EXPAND OUR OUTREACH EFFORT TO BETTER

EDUCATE CALIFORNIANS, TO IMPROVE, AGAIN, PEOPLE

TALKING ABOUT THIS PROGRAM, RECOGNITION OF THIS

PROGRAM, AND SUPPORT OF THE PROGRAM. AND, AGAIN, TO

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CONTINUE TO OPTIMIZE THE WORKFORCE STAFFING AND

MANAGEMENT TO MEET THE CHANGING PRIORITIES WITHIN

THAT 6-PERCENT CEILING THAT WE HAVE. SO I'M OPEN TO

ANY QUESTIONS OR DISCUSSIONS.

MS. LANSING: I WANT TO GET ON THE LIST TO

TALK.

CHAIRMAN THOMAS: HOLD ON, SHERRY, ONE

SECOND. DIANE HAS GOT A QUESTION, THEN WE'LL GO TO

YOU NEXT.

MS. WINOKUR: I THINK YOU SHOULD CALL

ATTENTION TO THE MEETING EARLIER THIS MONTH OF

ADVOCATES FROM ALL OVER THE STATE IN WHICH SEVERAL

MEMBERS OF THE CIRM STAFF HAD AN OPPORTUNITY TO

DESCRIBE CIRM PROGRAMS AND TAKE QUESTIONS. THAT WAS

A VERY GOOD CIRM PUBLIC AFFAIR.

DR. TROUNSON: IT WAS, DIANE. IT WAS

GREAT. I WASN'T UNFORTUNATELY THERE, BUT KEVIN IS

GOING TO TALK ABOUT THAT A LITTLE LATER, BUT I

ABSOLUTELY AGREE.

SHERRY, YOU HAD A COMMENT?

MS. LANSING: YES. WELL, MY COMMENT IS

THANK YOU, AND I AGREE WITH ALL THE GOALS THAT YOU

PUT FORWARD. BUT I WANTED TO PUT A SPECIAL EMPHASIS

FOR THE BOARD AND FOR ALL OF US. I AM, AS ALL OF US

ARE, GOING TO DO EVERYTHING WE POSSIBLY CAN TO GET A

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RENEWAL OF THE BOND MONEY. BUT I THINK WE HAVE TO

ALSO START TO PREPARE, AND THIS HAS TO BE A HIGH

PRIORITY, AND YOU DID MENTION IT, ABOUT REACHING OUT

TO PUBLIC/PRIVATE PARTNERSHIPS. AND I THINK WE

REALLY AS A BOARD, AND OBVIOUSLY YOU AND YOUR TEAM

REALLY NEED TO MAKE THAT, AND YOU DID MENTION IT. I

JUST WANT TO STRESS THAT I THINK IT HAS TO BE A HIGH

PRIORITY SO THAT ALL THE CLINICAL TRIALS THAT WE

HAVE, ALL THE WORK THAT'S BEEN GOING ON, GOD FORBID

IF WE DON'T GET A RENEWAL OF A BOND, THAT WE HAVE

ANOTHER POSSIBILITY TO CONTINUE THIS WORK. SO I

JUST WANTED TO --

DR. TROUNSON: I EMPHATICALLY AGREE,

SHERRY, THAT WE NEED TO. EVEN IF WE GET REFUNDING,

THAT'S ANOTHER WAVE OF ENABLING THAT PART OF IT AND

GETTING MORE PRIVATE PARTNERSHIPS. IT'S A REALLY

GOOD IDEA EVEN IF WE DID GET FUNDING.

MS. LANSING: WELL, YOU'RE RIGHT. AND YOU

SAID IT MORE ELOQUENTLY. SO LET ME AMEND WHAT I WAS

SAYING. YOU'RE ABSOLUTELY RIGHT. WE SHOULD DO BOTH

IS WHAT WE'RE SAYING. AND THANK YOU FOR CORRECTING

ME BECAUSE YOU ARE RIGHT. BUT WE MUST START TODAY

BECAUSE WE NEED THIS EXTRA MONEY TO CONTINUE OUR

WORK.

CHAIRMAN THOMAS: THANK YOU, SHERRY. I

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SHOULD NOTE THAT ON THE SUBJECT OF SUSTAINABILITY IN

GENERAL, THERE ARE A NUMBER OF OTHER THINGS, OTHER

INITIATIVES WE'RE PURSUING, WHICH AT THE APPROPRIATE

TIME WE'LL DISCUSS WITH THE BOARD, THAT DEAL WITH

SORT OF THE ORGANIZATIONWIDE NEED FOR ADDITIONAL

FUNDING. ALAN'S PROGRAM, AS HE'S SAID, IS TARGETED

PRINCIPALLY AT THE TRANSLATIONAL PART OF THE

PORTFOLIO TO ENABLE IT TO CONTINUE ALONG. SO A

COMBINATION OF ALL THESE EFFORTS, WE'RE MOST

HOPEFUL, WILL END UP WITH ADDITIONAL FUNDING TO

SUSTAIN THE AGENCY AND THE TRANSLATIONAL PORTFOLIO,

ETC.

MS. LANSING: THANK YOU. I'M GLAD YOU'RE

DOING THAT.

CHAIRMAN THOMAS: WE HAVE DEAN HAWGOOD

THEN DEAN PULIAFITO.

DR. HAWGOOD: ALAN, ALL OF THESE GOALS

WITH THE EXCEPTION OF THE FIRST ARE MORE OR LESS

UNDER THE STAFF'S AND BOARD'S CONTROL TO EXECUTE ON.

BUT TO HAVE THREE TO FIVE CLINICAL TRIALS ACTIVELY

ENROLLING PATIENTS GIVEN THE TIMELINE, IS THAT A

GOAL THAT WAS ESTABLISHED BASED ON YOUR ANALYSIS OF

WHAT'S PROBABLE?

DR. TROUNSON: YES. YEAH. WE FEEL THAT

WE CAN MAKE THAT, SAM. WE FEEL CONFIDENT THAT WE

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CAN DO THAT. AND WE'RE PRESSING HARD TO DO THAT.

WE'RE ENROLLING IN TWO PROJECTS AT THE MOMENT. SO

THAT'S A GREAT START. SO LET'S HOPE THAT WE'VE

DRIVEN IT UP TO THE FIVE ON THE OPTIMISTIC END. BUT

WE'RE IN THE GAME. WE'RE ACTUALLY IN THE GAME. SO

THAT'S REALLY IMPORTANT.

CHAIRMAN THOMAS: JOAN, IT'S DEAN

PULIAFITO IS FIRST, JOAN, AND THEN YOU.

MS. SAMUELSON: I JUST WONDERED IF YOU

COULD IDENTIFY THE TWO AND WHEN THEY STARTED.

DR. TROUNSON: I THINK IN THE CASE OF THE

HIV/AIDS WORK, IT'S RUNNING UNDER CAL-IMMUNE.

THEY'VE STARTED THEIR PATIENTS. I SEE JEFF NODDING

AND WE AGREED. AND IN THE CARDIOMYOCYTE WORK,

THEY'RE ENGAGING THEIR PATIENTS AS WELL. SO THERE'S

THE TWO.

DR. FEIGAL: THAT'S CORRECT.

MR. SHEEHY: CAL-IMMUNE INFUSED THEIR

FIRST PATIENT. I THINK KEVIN ISSUED A PRESS RELEASE

AND SO DID THE COMPANY, WHAT, LAST WEEK, WASN'T IT?

DR. TROUNSON: YEAH. YEAH.

MR. SHEEHY: THEY'VE ACTUALLY TREATED

THEIR FIRST PATIENT.

DR. TROUNSON: SO OTHERS ARE GETTING READY

AS WELL, BLUEBIRD, ETC. SO WE'RE HOPEFUL THAT WE

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CAN MEET THE UPPER LIMIT OF THIS. AND SO WE'RE

PUSHING REALLY HARD AND WORKING WITH THOSE TEAMS TO

MAKE SURE THAT WE GET THOSE UP AND AS MANY PATIENTS

AS POSSIBLE INTO THESE TRIALS.

MS. SAMUELSON: AND THE SECOND WAS WHAT?

DR. TROUNSON: THE CARDIOMYOCYTE WORK OUT

OF CEDARS-SINAI. AND WE EXPECT BLUEBIRD IN

THALASSEMIA TO BEGIN RELATIVELY SOON AS WELL, I

THINK, ELLEN, NOT TOO FAR OFF.

MS. SAMUELSON: SO THAT'S AN ONGOING

CLINICAL TRIAL, THE CARDIOMYOCYTE?

DR. FEIGAL: THERE ARE TWO ONGOING

CLINICAL TRIALS, ONE IN HIV AND ONE IN CARDIAC

DISEASE. AND THEN WE ANTICIPATE A THIRD ONE

STARTING BEFORE THE END OF THE YEAR. AND THEN WE

HAVE FOLLOWING THE THINGS, IF THINGS STAY ON TRACK,

WE ANTICIPATE MORE IN 2014.

MS. SAMUELSON: IT WOULD BE GOOD TO JUST

GET ON PAPER SO THAT WE CAN REFER TO IT AND NOT HAVE

TO KEEP ALL THIS IN OUR HEADS.

DR. FEIGAL: YOU KNOW, AT THE PREVIOUS

BOARD MEETING, I GAVE AN UPDATE ON EACH OF THE TEAMS

AND WHERE THEY ARE, AND WE'D BE HAPPY TO CONTINUE

THOSE UPDATES SO YOU'RE AWARE.

MS. SAMUELSON: IN THE SAME CONTEXT OF OUR

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DECISION-MAKING BECAUSE IT SHIFTS FROM TIME TO TIME.

CHAIRMAN THOMAS: I WOULD LIKE TO NOTE ON

THIS POINT THAT THIS IS, NOT TO GLOSS OVER THIS TOO

QUICKLY, THIS IS A LANDMARK DEVELOPMENT FOR CIRM TO

GET THE FIRST OF OUR PROJECTS INTO HUMAN CLINICAL

TRIALS AND THE FIRST OF WHAT PROMISE TO BE MANY AND

REALLY HIGHLIGHTS, THOUGH INCREMENTAL, THE DECIDED

PROGRESS THAT OUR SCIENTISTS ARE MAKING TOWARDS

ACHIEVING OUR GOAL OF DEVELOPING THERAPIES AND

CURES. THIS IS A VERY BIG DEAL TO HAVE THESE TWO GO

INTO CLINICAL TRIALS THAT WE'RE UNDERWRITING HERE.

DR. TROUNSON: THAT'S RIGHT. DON'T

FORGET, JON, THEY'RE THE DISEASE TEAMS. WE'VE HAD

OTHERS GO IN CANCER, MYELOFIBROSIS.

CHAIRMAN THOMAS: YES. BUT FOR THE

DISEASE TEAMS, THOSE TWO FIRST BIG HITS. DEAN

PULIAFITO.

DR. PULIAFITO: CAN YOU PROVIDE THE BOARD

WITH AN ITEMIZED LIST OF THE $52 MILLION IN PRIVATE

COMMITMENTS --

DR. TROUNSON: YEAH.

DR. PULIAFITO: -- TO CIRM? AND WHAT'S A

GREAT EXAMPLE OF THAT? GIVE ME THE BEST EXAMPLE.

DR. TROUNSON: WELL, OUR COLLABORATIVE

FUNDING PARTNERS HAVE BROUGHT $5.3 MILLION IN

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COLLABORATIVE PROJECTS IN THIS LAST 12 MONTHS.

DR. PULIAFITO: HOW DOES THAT WORK THOUGH?

DR. TROUNSON: SO THESE ARE PROJECTS THAT

COME TOGETHER. THEY'RE CONSIDERED AS A COMPLETE

PROJECT BY THE GRANTS WORKING GROUP. AND SO WE PAY

FOR THE CALIFORNIA PART AND THE OTHER AGENCY OR

OTHER COUNTRY PAYS FOR THE OUT OF CALIFORNIA. SO

THAT WAS 5.3 MILLION.

THERE WERE MATCHING FUNDS OF 53.4

MILLION, AND THESE ARE MATCHING FUNDS FROM THE

DISEASE TEAM COMPANIES IN OUR STRATEGIC PARTNERING

AND IN OUR DISEASE TEAMS THAT CAME.

AND THERE WAS A SUPPLEMENTAL GRANT THAT

CAME WITH VIACYTE FROM JDRF OF THREE MILLION.

DR. PULIAFITO: I'D JUST LIKE TO MAKE A

CLARIFYING POINT. I THINK THIS IS WONDERFUL, BUT

WHAT THIS DOESN'T HAPPEN -- WHAT'S NOT HAPPENING IS

NOT -- AN OUTSIDE AGENCY ISN'T GIVING YOU MONEY THAT

YOU CAN DISTRIBUTE TO THE SCIENTISTS OF CALIFORNIA

IN A WAY THAT CIRM SEES FIT. AND THE POINT I NEED

TO MAKE ABOUT THAT IS YOU SEE THAT THERE REALLY IS

NO SUBSTITUTE FOR CIRM AND THE STATE FUNDS.

AND I'LL TELL YOU JUST AS -- I MEAN SO

WE'RE NOT GOING TO RESCUE THE PROGRAM JUST WITH

THESE PUBLIC/PRIVATE PARTNERSHIPS ON VERY DESIGNATED

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SPECIFIC THINGS.

DR. TROUNSON: OKAY. BUT IN THE CASE OF

THE PARTNERSHIPS WITH THE COMPANIES, THEY'RE PUTTING

THEIR MONEY INTO THE PROJECT AS WELL AS US. SO THIS

IS -- WE CAN'T DO THOSE PROJECTS WITHOUT THAT MONEY.

SO YOU KNOW IT IS THE SAME CASE THAT THE GRANTS

WORKING GROUP REVIEW THE WHOLE OF THE PROJECT, BOTH

OURS AND THE OTHER, AS AN INTEGRATED PART OF THE

PROJECT. SO THE DECISIONS WERE MADE ON THE WHOLE

PROJECT, NOT JUST OUR PART OF IT. BUT I TAKE YOUR

POINT. I THINK YOU MADE YOUR POINT. WE'VE GOT

OTHER THINGS TO DO TO RAISE MONEY THAT WE CAN

ALLOCATE VERY SPECIFICALLY.

CHAIRMAN THOMAS: OKAY. I BELIEVE WE NEED

A MOTION TO APPROVE THE STRATEGIC PLAN GOALS FOR

FISCAL '13-'14.

MS. LANSING: I'LL MOVE IT.

CHAIRMAN THOMAS: MOVED BY SHERRY.

MR. TORRES: SECOND.

CHAIRMAN THOMAS: SECONDED BY, I THINK

THAT WAS, SENATOR TORRES; BUT IF NOT, I KNOW HE

MEANT TO SAY THAT. ALL THOSE IN FAVOR PLEASE SAY

AYE. OPPOSED? ON THE PHONE?

MS. LANSING: AYE.

DR. FINE: YES. AYE.

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CHAIRMAN THOMAS: ANY ABSTENTIONS?

HEARING NONE, THE MOTION PASSES. THANK YOU, DR.

TROUNSON. YOU MIGHT -- YES. THANK YOU.

SO WE'RE GOING TO HEAD NOW RIGHT INTO ITEM

7, WHICH IS CONSIDERATION OF CONCEPT -- OH.

ACTUALLY WE'RE GOING TO GIVE OUR STENOGRAPHER A

QUICK BREAK.

MS. SAMUELSON: MR. CHAIRMAN, ONE

QUESTION.

CHAIRMAN THOMAS: YES. HOLD ON ONE

SECOND, JOAN, IF YOU WOULD, PLEASE. I WAS DULY

NOTED I FORGOT TO GET PUBLIC COMMENT ON THAT LAST

MOTION. IS THERE ANY? YES. DON, PLEASE APPROACH

THE PODIUM.

MR. REED: ONE OF THE MOST IMPRESSIVE

THINGS IN THE WORLD IS THE MICROLOANS WHICH ARE

GIVEN OUT IN INDIA TO SMALL BUSINESSES, VERY SMALL

AMOUNTS OF MONEY, BUT THEY BRING TREMENDOUS RESULTS.

THE ROMAN REED ACT HAS ALWAYS BEEN VERY SMALL

GRANTS, BUT BECAUSE THEY GET A SMALL GRANT, THERE

WAS OFTEN A BIG FOLLOW-UP. ONE OF THOSE SMALL

GRANTS BECAME THE GERON TRIALS. I WOULD LIKE TO SEE

CONSIDERATION GIVEN TO JUST A SERIES OF SMALL GRANTS

WHICH WILL BE JUST LIMITED, JUST VERY SMALL BECAUSE

A SCIENTIST COULD GET A TRACK RECORD WITH THAT, GET

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INITIAL DATA, AND GO TO THE NIH AND SAY, LOOK, THIS

IS WHAT I HAVE DONE, NOT WHAT I WOULD LIKE TO DO,

BUT THIS IS WHAT I HAVE DONE. I HAVE A TRACK

RECORD.

SO I WOULD REALLY LIKE TO SEE THE ICOC

GIVE SERIOUS CONSIDERATION AS WE WIND DOWN THE

AMOUNT OF MONEY THAT WE HAVE TO A COUPLE MILLION

DOLLARS OF JUST SMALL GRANTS.

CHAIRMAN THOMAS: THANK YOU FOR THAT

SUGGESTION, MR. REED.

NOW, LET'S MOVE TO ITEM 7 -- YOU NEED A

QUICK BREAK. YOU'RE OKAY. OKAY. THANK YOU.

MS. SAMUELSON: I HAVE ONE MORE QUICK

QUESTION.

CHAIRMAN THOMAS: YES.

MS. SAMUELSON: IT WOULD BE HELPFUL IF WE

HAD A TIME FRAME FOR FEEDBACK ON THE TWO CLINICAL

TRIALS THAT HAVE BEEN FUNDED SO THAT WE CAN --

SOUNDS LIKE OUR DECISION-MAKING IS GOING TO BE MORE

FOCUSED AND IN SHORTER INCREMENTS OF TIME THAN IT

HAS BEEN IN THE PAST. SO WE NEED TO BE STAYING UP

TO DATE ON HOW THEY'RE DOING. AND OUR PAST CLINICAL

TRIALS WENT THROUGH ROUGH SLEDDING, AND I DON'T

THINK WE HAVE ANY OTHER. WE FUNDED TWO BEFORE, BOTH

OF WHICH I DON'T THINK ARE PENDING NOW. SO WE JUST

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HAVE THESE TWO NEW ONES. AND I'D JUST LIKE TO HAVE

A SENSE OF WHAT KIND OF UPDATES AND IN WHAT TIME

FRAMES WE WOULD GET THEM ABOUT THE PROGRESS OF THOSE

CLINICAL TRIALS AND ANY THAT JOIN THEM.

CHAIRMAN THOMAS: DR. TROUNSON.

DR. TROUNSON: WELL, IT'S A LITTLE

DIFFICULT, SORRY, TO FOLLOW THE WHOLE OF WHAT YOU'RE

ASKING. I'M SORRY. I WAS TRYING TO CONCENTRATE.

ELLEN FEIGAL, OF COURSE, BRINGS THE PROGRAM TO YOU

ON A REGULAR BASIS. AND IF YOU FEEL THAT WE COULD

INCLUDE WHAT WE KNOW IN TERMS OF PROGRESS IN THE

CLINICAL TRIALS, IF WE GET IT INTO A NEWSLETTER FOR

YOU, I THINK WE COULD TRY AND DO THAT TOO. BUT

SHE'S REALLY UPDATING THE BOARD FAIRLY FREQUENTLY ON

THIS, AND WE CAN CERTAINLY EXPECT HER TO LET YOU

KNOW WHEN THERE'S ANY CHANGE, WHEN THERE'S SOMETHING

NEW HAPPENING. SO WE DON'T ALWAYS -- OF COURSE, WE

DON'T ALWAYS KNOW SOME OF THE THINGS UNTIL A LITTLE

LATER BECAUSE THE COMPANIES THEMSELVES WANT TO

PROGRESS THINGS IN A WAY WHICH IS NOT PUBLIC. SO

GIVEN THAT PART, WE'LL GET ELLEN TO KEEP THE BOARD

AS WELL INFORMED AS WE CAN. OKAY.

MS. SAMUELSON: AND IN SUFFICIENT SCOPE

THAT WE CAN MAKE THE DECISIONS THAT WE HAVE TO MAKE

GOING FORWARD.

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CHAIRMAN THOMAS: I THINK DR. FEIGAL DOES

A VERY GOOD JOB OF KEEPING US UPDATED AS

DEVELOPMENTS OCCUR. SO I THINK THAT WILL BE VERY

HELPFUL, JOAN, IN HELPING YOUR DECISION-MAKING

PROCESS AS WELL AS THE BOARD.

MS. SAMUELSON: WE'LL NEED THE WEEDS AT

THIS POINT.

CHAIRMAN THOMAS: WE DON'T WANT TO GET TOO

FAR INTO THE WEEDS. WANT TO MAKE SURE THAT ALL OF

THE BOARD FOLLOWS EVERYTHING THAT'S GOING ON THERE,

BUT POINT WELL TAKEN. SO THANK YOU.

ALL RIGHT. ITEM 7 IS CONSIDERATION OF THE

ALPHA CLINIC CONCEPT PROPOSAL. DRS. DEWITT AND

MILLAN.

DR. DEWITT: GOOD MORNING, MR. CHAIRMAN,

MEMBERS OF THE BOARD, AND MEMBERS OF THE PUBLIC.

TODAY WE'RE GOING TO PRESENT THE CONCEPT PROPOSAL

FOR THE ALPHA STEM CELL CLINICS. BUT FIRST I'D LIKE

TO SHOW YOU A SHORT VIDEO THAT WAS TAKEN OF A

WORKSHOP THAT WE HELD LAST FALL WHERE WE BROUGHT

TOGETHER STAKEHOLDERS AND EXPERTS IN THE FIELD OF

STEM CELL THERAPY DEVELOPMENT TO ASK HOW THE CLINICS

IN CALIFORNIA CAN MORE EFFECTIVELY TEST AND DELIVER

STEM CELL THERAPIES.

(VIDEO WAS THEN SHOWN, NOT REPORTED

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NOR HEREIN TRANSCRIBED.)

DR. DEWITT: I WANT TO THANK TODD

DUBNICOFF FOR MAKING A GREAT VIDEO. I THINK IT DOES

A GOOD JOB OF CAPTURING THE EXCITEMENT AT THE

WORKSHOP FOR CIRM ESTABLISHING A FOOTPRINT IN THE

CLINICAL ARENA.

SO I'LL START BY SETTING THE STAGE A BIT

AND EXPLAIN WHY IT'S SUCH A CRITICAL TIME FOR CIRM

TO INITIATE FUNDING SUCH A CLINICAL NETWORK.

THROUGH VARIOUS FORMS OF RESEARCH THAT WE'VE DONE AT

CIRM, INCLUDING THE WORKSHOP AND INTERVIEWS WITH A

VARIETY OF STAKEHOLDERS AND EXPERTS, WE FOUND THAT

THERE'S SIGNIFICANT UNMET NEEDS IN THE CLINICAL

INFRASTRUCTURE FOR STEM CELL THERAPIES. AS A

FUNDING AGENCY WITH THE MISSION OF DRIVING STEM CELL

RESEARCH FORWARD AND STEM CELL THERAPIES FORWARD,

IT'S IMPORTANT THAT WE ANTICIPATE THESE UNMET NEEDS

AND START PUTTING IN PLACE THE MISSING COMPONENTS.

SO AS YOU ALL WELL KNOW, CIRM AND OTHER

FUNDERS HAVE MADE AN ENORMOUS COMMITMENT OF FUNDING

IN STEM CELL RESEARCH DURING THE PAST DECADE, AND

IT'S HOPED THIS HAS FINALLY LED TO AN INCREASED

NUMBER OF INVESTIGATIONAL STEM CELL THERAPIES IN THE

PIPELINE. SO WE HAVE EVERY REASON TO BELIEVE THAT

THIS ACTIVITY WILL CONTINUE IN UPCOMING DECADES.

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SO COMPOUNDING THE EFFECTS OF INCREASED

ACTIVITY IS THE UNIQUE SET OF CHALLENGES THAT THESE

TYPES OF PRODUCTS PRESENT. THIS CAN INCLUDE THE

NEED FOR TRACKING THE CELLS IN THE PATIENTS,

HANDLING THE CELLS IN SPECIALIZED CLEAN ROOMS, BEING

ABLE TO PERFORM GENE MODIFICATION ON THE CELLS, AND

THE NEED FOR COLLECTING AND MANAGING DATA, AND THE

LENGTHY FOLLOW-UP STUDIES THAT ARE NEEDED FOR

SAFETY.

SO THE ALPHA STEM CELL CLINICS NETWORK

WOULD HAVE AS ITS MISSION THE CREATION OF RESOURCES,

KNOW-HOW, AND EFFICIENCIES TO ACCELERATE CLINICAL

TESTING AND DELIVERY OF STEM CELL PRODUCTS. THE

PROPOSED NETWORK WOULD ALIGN CLOSELY WITH CIRM'S

STRATEGIC PLAN, WHICH IS DIVIDED INTO THREE PHASES.

CURRENTLY CIRM IS IN THE MIDDLE OR THE FOCUS PHASE

WHERE OUR KEY GOAL IS TO DRIVE CLINICAL TRIALS FOR

PATIENTS TO GENERATE PRELIMINARY EVIDENCE OF BENEFIT

AND, OF COURSE, SAFETY.

STARTING IN 2016 CIRM WILL START THE

DELIVERY PHASE WHERE THE FOCUS WILL BE ON ADVANCING

THERAPIES TO PATIENTS, FACILITATING THE

COMMERCIALIZATION OF THERAPIES, AND ENABLING

BUSINESS MODELS FOR STEM CELL-BASED THERAPIES.

SO THE ALPHA CLINICS NETWORK WILL SUPPORT

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BOTH OF THESE CRUCIAL PHASES AND IN DOING SO

ACCELERATE THE OVERALL MISSION OF CIRM AND PROP 71,

WHICH IS TO SUPPORT THE DEVELOPMENT AND DELIVERY OF

THERAPIES AND CURES FOR PEOPLE WHO NEED THEM.

SO THE NETWORK WOULD HAVE FIVE MAJOR GOALS

AS WE PROPOSE. THE FIRST IS CLINICAL TRIALS TO

IMPROVE THE EFFECTIVENESS AND EFFICIENCY OF CLINICAL

TRIALS FOR INVESTIGATIONAL STEM CELL PRODUCTS.

SECOND, THE DELIVERY OF THERAPIES TO CREATE CENTERS

OF EXCELLENCE FOR DELIVERY OF STEM CELL-BASED

THERAPIES PROVEN SAFE AND EFFECTIVE.

THIRD, DATA AND INFORMATION MANAGEMENT.

TO COMPILE AND APPROPRIATELY AND SECURELY SHARE

CLINICAL TRIAL DATA AND EXPERIENCE TO INFORM A

VARIETY OF IMPORTANT POLICYMAKERS, RESEARCHERS, AND

CLINICIANS, AS WELL AS THE PUBLIC.

FOURTH, PUBLIC EDUCATION, TO BETTER INFORM

THE PUBLIC BY DEVELOPING EDUCATION AND OUTREACH

PROGRAMS, PATIENT COUNSELING PROGRAMS TO ADVISE ON

WHAT CLINICAL TRIALS ARE AVAILABLE IN THE NETWORKS

AND OUTSIDE OF IT, AND TO EDUCATE PEOPLE ON THE

POTENTIAL DANGERS OF UNTESTED STEM CELL-BASED

PROCEDURES THAT ARE OFFERED WORLDWIDE, AS YOU ALL

KNOW, I'M SURE.

SO FINALLY, HEALTHCARE ECONOMICS. THE

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ALPHA CLINICS CAN HELP WITH THE SUSTAINABILITY OF

THESE NEW THERAPIES BY PROVIDING A PROVING GROUND

FOR NEW BUSINESS MODELS AND TO DEVELOP A BASE OF

EVIDENCE TO INFORM EVENTUAL COVERAGE DECISIONS BY

INSURANCE COMPANIES AND HEALTHCARE PROVIDERS FOR

APPROVED THERAPIES ONCE THEY BECOME AVAILABLE.

SO THE SCOPE OF THE ALPHA CLINICS WILL BE

LIMITED TO THE SUPPORT OF CONCEPTUALLY NOVEL STEM

CELL-BASED THERAPIES AS OPPOSED TO MODIFICATIONS OF

THOSE IN CURRENT MEDICAL PRACTICE. IN ADDITION, THE

PROCEDURES SHOULD INVOLVE TRANSPLANTATION OR

INFUSION OF CELLS AS OPPOSED TO TESTING AND DELIVERY

OF SMALL MOLECULES OR BIOLOGICS.

SO WE PROPOSE THAT THE NETWORK WOULD HAVE

TWO MAJOR COMPONENTS, A NETWORK OF CLINICS AND AN

ORGANIZING CENTER. WE PROPOSE SEEDING UP TO FIVE

CLINICS IN EXISTING MEDICAL CENTERS THROUGHOUT

CALIFORNIA. THESE CLINICS WILL CONDUCT CLINICAL

TRIALS FOR STEM CELL-BASED INVESTIGATIONAL

THERAPIES, PROVIDE COUNSELING AND INFORMATION FOR

PATIENTS AND POTENTIAL CLINICAL TRIAL SUBJECTS, AND

EVENTUALLY BECOME THE GO-TO SITE FOR PATIENTS TO

RECEIVE A VARIETY OF THERAPIES.

THE CLINICAL SITES WILL BE LINKED BY A

COORDINATION AND INFORMATION MANAGEMENT CENTER,

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WHICH WE'RE CALLING THE CIMC. THE MAJOR ACTIVITIES

OF THE CENTER WILL BE TO CREATE OUTREACH, EDUCATION,

AND TRAINING RESOURCES AND TO BUILD A TEAM OF

COUNSELORS TO WORK DIRECTLY WITH PATIENTS. THERE

WILL ALSO BE A GROUP OF EXPERTS TO PROVIDE

CONSULTING SERVICES TO THE CLINICS AND THE CLINICAL

TRIAL SPONSORS AND WHO WILL CONSOLIDATE INFORMATION

GAINED THROUGH ACTIVITIES THROUGHOUT THE NETWORK.

THE CIMC WILL CREATE A DATABASE OF INFORMATION SUCH

AS PATIENT REGISTRIES, CLINICAL TRIAL DATA, ALL

WHICH WILL BECOME A VALUABLE RESOURCE FOR HEALTHCARE

POLICY AND RESEARCH. AND FINALLY, THE CIMC WILL

ALSO HAVE A STAFF WITH EXPERTISE IN HEALTHCARE

ECONOMICS AND BUSINESS DEVELOPMENT, AS I MENTIONED,

TO CREATE MODELS FOR SUSTAINABILITY AND WORK WITH

HEALTHCARE ORGANIZATIONS AND ACCOUNTABLE CARE

ORGANIZATIONS AND INSURERS TO ESTABLISH PRICING AND

PAYMENT MODELS.

SO THE LONG-TERM GOAL IS TO CREATE A

ROBUST AND ACTIVE NETWORK OF CLINICAL TRIALS IN

CALIFORNIA. IT WILL PROVIDE CLINICAL TRIAL SITES

FOR CIRM-FUNDED DISEASE TEAMS AS WELL AS OTHER

INVESTIGATORS AND COMPANIES INSIDE AND OUTSIDE OF

CALIFORNIA. CIRM IS CURRENTLY FUNDING OVER 25

CLINICAL TRIALS AND TWO STRATEGIC PARTNERSHIPS, ALL

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ADDRESSING A VARIETY OF MEDICAL NEEDS. SO FROM THE

CIRM PIPELINE ALONE WE ANTICIPATE TEN DISEASE TEAMS

WILL HAVE AN EARLY PHASE CLINICAL TRIAL IN PROGRESS

BY THE END OF 2017. ADDITIONAL ACTIVITY WILL COME

FROM ACADEMIC- AND INDUSTRY-SPONSORED CLINICAL

SPONSORS OUTSIDE CALIFORNIA OR INSIDE CALIFORNIA.

THE CLINICS WILL ESTABLISH A BRAND OF EXCELLENCE IN

STEM CELL-BASED THERAPIES THAT WILL EVENTUALLY

ATTRACT PATIENTS SEEKING APPROVED THERAPIES FOR A

VARIETY OF CONDITIONS.

THE INTERACTIONS BETWEEN ALL THE

COMPONENTS OF THIS NETWORK, AS SHOWN HERE, INCLUDING

THE NONFUNDED COMPONENTS, SUCH AS PATIENTS AND THE

CLINICAL TRIAL SPONSORS, IS AN UNDERTAKING WITH A

LOT OF ORGANIZATIONAL COMPLEXITY. AND SO,

THEREFORE, THIS PROPOSAL CAME FROM A TEAM OF US AT

CIRM WITH COMBINED EXPERTISE IN STEM CELL RESEARCH,

CLINICAL RESEARCH AND MEDICINE, PUBLIC HEALTH,

BUSINESS DEVELOPMENT, AND REGULATORY ISSUES.

SO NOW I'LL PASS THE PRESENTATION OVER TO

ONE OF THE MEMBERS OF THIS TEAM, MARIA MILLAN, WHO

HAS THE CLINICAL AND MEDICAL EXPERTISE.

DR. MILLAN: THANK YOU, NATALIE. AND GOOD

MORNING, MEMBERS OF THE BOARD AND MEMBERS OF THE

PUBLIC.

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SO WE THOUGHT THAT IN THE NEXT FEW MOMENTS

IT WOULD BE HELPFUL TO JUST DESCRIBE HOW SUCH A

NETWORK WOULD OPERATE AND WHAT VALUE THIS WOULD

BRING TO PATIENTS, TO THE MEDICAL COMMUNITY, AND TO

CLINICAL RESEARCH COMMUNITY.

SO CURRENTLY PATIENTS WITH DEBILITATING OR

SOMETIMES FATAL DISEASES ARE SEEKING ALTERNATIVES TO

WHAT'S AVAILABLE OUT THERE. AND NOW THAT THERE IS

MUCH MORE PROGRESS IN THE FIELD OF STEM CELLS, THEY

ARE HEARING MORE IN THE PRESS, MAYBE IN

PUBLICATIONS, AND OFTEN IN THE INTERNET. AND

THERE'S A HUGE AMOUNT OF INFORMATION THAT'S OUT

THERE, AND IT'S VERY DIFFICULT FOR THEM, EVEN

SOPHISTICATED AND EDUCATED PATIENTS, TO SORT THROUGH

THIS MATERIAL AND FIGURE OUT WHAT ARE LEGITIMATE

ACTIVITIES VERSUS NOT. AND THERE'S REALLY NO ONE

PLACE OR NO RESOURCE THAT THEY CAN USE, AND EVEN

THEIR PHYSICIANS OFTEN WOULD NOT HAVE THAT

INFORMATION TO HELP THEM.

AND SO THIS OFTEN LEADS TO MORE QUESTIONS,

CONFUSION, SOMETIMES A SENSE OF DESPERATION,

HONESTLY, AND SOME WILL SEEK DANGEROUS, UNPROVEN,

UNREGULATED TREATMENTS ABROAD OR ELSEWHERE AND

ACTUALLY PAY FOR THESE.

WITH ESTABLISHMENT OF AN ALPHA CLINICS

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NETWORK WITHIN REPUTABLE AND ESTABLISHED MEDICAL

CENTERS THROUGHOUT CALIFORNIA, THESE PATIENTS AND

THEIR FAMILIES WOULD THEN HAVE SOMEWHERE TO GO.

THERE WOULD BE PATIENT COUNSELORS WHO WOULD BE ABLE

TO BRING THEM INFORMATION AND DATA-DRIVEN MATERIALS

THAT WOULD BE ASSEMBLED AND VETTED THROUGH THE CIMC

AND THE EXPERTISE THAT THAT WOULD DRAW, AS WELL AS

COLLECTIVE INPUT FROM ALL OF THE PARTICIPATING ALPHA

NETWORKS AND THEIR COLLABORATORS.

SO WHETHER THE PATIENTS END UP ENROLLING

AT ONE OF THE ALPHA CLINICS OR ELSEWHERE FOR A

CLINICAL TRIAL, THEY'RE BETTER INFORMED AS TO WHAT

CONSTITUTES LEGITIMATE TRIALS AND TREATMENTS AND

BETTER INFORMED TO MAKE DECISIONS ABOUT

PARTICIPATION IN VARIOUS TRIALS. IF THERE ARE NO

TRIALS AVAILABLE OUT THERE AT THAT TIME, THEY WOULD

BE IN THE PATIENT REGISTRY AND THEY COULD BE

CONTACTED SHOULD THERE BE SOMETHING DOWN THE PIKE

THAT MAY BE APPROPRIATE FOR THEM.

AND IF THEY DO ENROLL IN A CLINICAL TRIAL

AT ONE OF THESE SITES, THEY WOULD BE CARED FOR BY AN

EXPERIENCED AND SPECIALIZED CLINICAL TRIAL TEAM THAT

WOULD HAVE SPECIALIZATION AND EXPERTISE AND

EXPERIENCE WITH RUNNING STEM CELL TRIALS. THAT TEAM

WOULD BE SUPPORTED BY THE RESOURCES AS DESCRIBED AT

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THE CIMC. IT WOULD BE FULLY INTEGRATED WITHIN THE

MEDICAL CENTER AND THE MEDICAL NETWORK WHERE THEY

WOULD BE ABLE TO LEVERAGE THE MEDICAL SPECIALTIES,

RESOURCES, AND INFRASTRUCTURE OF THAT INSTITUTION

AND PARTNER INSTITUTIONS.

I JUST WANT TO REEMPHASIZE THAT WE DON'T

PROPOSE DUPLICATING OR RECREATING RESOURCES THAT

ALREADY EXIST. TO THE CONTRARY, THE IDEA IS THAT

THESE HOST INSTITUTIONS FOR THE ALPHA CLINICS WOULD

LEVERAGE THEIR RESOURCES TOWARDS SUPPORTING THE

CLINICAL TRIALS AND THE ACTIVITIES AT THESE CLINICS.

SO WHY WOULD SPONSORS AND RESEARCHERS AND

EVENTUALLY CLINICIANS REFER THEIR PATIENTS TO THESE

CLINICS? WELL, FIRSTLY, THERE WOULD BE A VERY

EXPERIENCED ALPHA CLINICAL TRIAL TEAM WITH THE

EXPERIENCE AND EXPERTISE TO EXECUTE THESE PROJECTS.

IN ADDITION, THEY WOULD HAVE ACCESS TO PATIENT

REGISTRIES. AND WITH TIME THAT WOULD BUILD

INITIALLY DISEASE SPECIFIC. MAYBE PATIENTS WHO HAVE

INTEREST IN STEM CELL TRIALS WOULD BE ENTERED INTO

THE REGISTRIES AS WELL. ACTUALLY THEY WOULD BE.

AND THEY WOULD BE ABLE TO ACCESS THESE REGISTRIES.

AND AS WE KNOW, ENROLLMENT IS A MAJOR GATING ITEM

FOR CLINICAL TRIALS. SO THIS WOULD BE OF GREAT

VALUE TO THESE SPONSORS.

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IN ADDITION, THEY WOULD HAVE ACCESS TO

CLINICAL AND REGULATORY SUPPORT AS WELL AS BENEFIT

FROM THE COLLECTIVE KNOW-HOW, ACCELERATED LEARNING,

AND EXPERIENCES THAT ARE EMBODIED AND CONSOLIDATED

WITHIN THE CIMC BY ALL THE PARTICIPATING ALPHA

CLINIC SITES.

IN ADDITION, THE CIMC WOULD HAVE

ESTABLISHED RELATIONSHIPS WITH PARTICIPATING

INSTITUTIONS AND ALPHA CLINICS, AND THIS WOULD BUILD

EFFICIENCIES INTO THE SYSTEM WITH PROCESSES SUCH AS

IRB SUBMISSION SO THAT PROPER IRB REVIEWS COULD TAKE

PLACE IN A TIMELY MANNER WITH APPROPRIATE INPUT FROM

THOSE WHO HAVE EXPERIENCE IN THE FIELD. AND ALSO

WITH MATTERS SUCH AS CLINICAL TRIAL AGREEMENTS, FOR

INSTANCE, WHERE THERE COULD BE MODEL AGREEMENT FORMS

OR MAYBE EVEN STANDARD AGREEMENT FORMS THAT COULD BE

APPROPRIATELY MODIFIED FOR A GIVEN TRIAL. AND ALL

OF THIS WOULD TRANSLATE INTO TIMELINE EFFICIENCIES

AND COST SAVINGS FOR THE CLINICAL TRIAL SPONSORS.

WITH THIS VISION AND SCOPE IN MIND, WE

PROPOSE THE FOLLOWING ELIGIBILITY CRITERIA FOR THE

APPLICANTS OR THE SUCCESSFUL APPLICANT. THE ALPHA

CLINICS WOULD BE WITHIN CALIFORNIA INSTITUTIONS,

CALIFORNIA MEDICAL CENTERS, AND WE PROPOSE LIMITING

ONE ALPHA CLINIC AWARD PER INSTITUTION. THE PI AND

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TEAM WOULD HAVE A STRONG TRACK RECORD IN MEDICAL

CARE AND CLINICAL RESEARCH, AND THERE WOULD BE

DEMONSTRATION OF STRONG INSTITUTIONAL COMMITMENT TO

LEVERAGE EXISTING INFRASTRUCTURE AND RESOURCES, NOT

JUST AT THE HOSPITAL, BUT IN TERMS OF RESOURCES

REGARDING EXPERTISE IN NETWORKS THAT MAY ALREADY BE

IN PLACE AT THOSE INSTITUTIONS. THEY WOULD HAVE A

STRONG TRACK RECORD FOR CLINICAL TRIALS AND A LARGE

PATIENT BASE AND REFERRAL BASE.

A CRITICAL PIECE OF THIS IN ASSURING THAT

THESE CLINICS WON'T JUST BE ESTABLISHED AND SITTING

THERE IS THAT THESE ALPHA CLINICS MUST DEMONSTRATE

AND IT WILL BE A REQUIREMENT THAT THEY COULD

INITIATE AT LEAST ONE STEM CELL CLINICAL TRIAL

WITHIN 12 MONTHS OF THE AWARD DATE. THEY WOULD BE

ASKED TO SUBMIT A CREDIBLE AND STRONG SUSTAINABILITY

PLAN FOR THOSE CLINICS AS WELL AS DEMONSTRATE ONWARD

ACTIVITIES WITH A PROMISE OF A PIPELINE OF STEM CELL

CLINICAL TRIALS AND ACTIVITIES.

THE CIMC WOULD BE AN EXISTING CALIFORNIA

FOR-PROFIT OR NOT-FOR-PROFIT ENTITY WITH A STRONG

TRACK RECORD IN CLINICAL TRIAL MANAGEMENT AND

SUPPORT, MUCH OF THE CORE COMPETENCIES THAT ARE

OFTEN CLASSICALLY EMBODIED WITHIN CONTRACT RESEARCH

ORGANIZATIONS, BUT ARE NOW ALSO WITHIN ACADEMIC

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MEDICAL CENTERS. IN-HOUSE EXPERTISE THAT WOULD BE

VALUABLE FOR CLINICAL TRIAL MANAGEMENT AND SUPPORT.

AND THE PI WITH STRONG MANAGEMENT AND ADMINISTRATIVE

SKILLS WHICH IS CRITICAL TO BRING ALL THESE PIECES

TOGETHER. AND THE CIMC WOULD ALSO FORM A STEERING

COMMITTEE WITH REPRESENTATION FROM THE ALPHA CLINICS

AND A COMMITMENT TO SET UP PUBLIC EDUCATION AND

OUTREACH ACTIVITIES, WHICH, AS WE MENTIONED, IS A

CRITICAL PIECE TO THIS INITIATIVE.

TO FUND THIS, WE'RE PROPOSING TO THE BOARD

$70 MILLION TO FUND TWO RFA'S, REQUESTS FOR

APPLICATIONS, UP TO $55 MILLION TO FUND UP TO FIVE

ALPHA CLINICS, AND UP TO $15 MILLION TO FUND A

CENTRAL INFORMATION -- COORDINATING AND INFORMATION

CENTER. THESE WOULD BOTH BE AWARDS THAT WOULD BE

FOR THE LENGTH OF FIVE YEARS.

SHOULD THIS CONCEPT BE APPROVED BY THE

BOARD TODAY, WE TARGET A RELEASE OF THE REQUEST FOR

APPLICATIONS IN OCTOBER OF 2013, AND WE'LL BE

BRINGING BACK TO THIS BOARD FUNDING RECOMMENDATIONS

IN JULY 2014, NEXT YEAR.

SO BEFORE I END, I'D LIKE TO THANK THE

BOARD AND THE PUBLIC FOR THEIR ATTENTION AND FOR

ALLOWING US TO BRING THIS CONCEPT FORWARD TO YOU.

AND ON BEHALF OF THE CIRM STAFF AND THE INVOLVEMENT

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AS SHOWN ON THIS ACKNOWLEDGEMENT SLIDE, I'D LIKE TO

THANK YOU FOR CONSIDERING THE ALPHA CLINICS CONCEPT,

AND WE HOPE THAT WE'VE CONVEYED THE IMPORTANCE OF

SUCH AN INITIATIVE IN TERMS OF BRINGING CIRM TO ITS

NEXT PHASE OF ACCOMPLISHING ITS MISSION, WHICH IS TO

BRING STEM CELL THERAPIES INTO THE CLINIC.

SO AT THIS TIME I'D LIKE TO ENTERTAIN

QUESTIONS. AND NATALIE DEWITT AND I WILL BE HAPPY

TO ENTERTAIN THE QUESTIONS AS WELL AS OUR COLLEAGUES

WHO HAVE BEEN INTEGRAL TO THIS CONCEPT PROPOSAL

DEVELOPMENT. THANK YOU.

CHAIRMAN THOMAS: THANK YOU. MR. SHEEHY.

MR. SHEEHY: I JUST WANT TO COMPLIMENT DR.

TROUNSON, AND I'D MENTION STAFF MEMBERS BY NAME, BUT

I THINK I'D BE HERE ALL DAY. I THINK THIS IS JUST A

TREMENDOUS EFFORT. AND HAVING SEEN A LOT OF THE

WORK THAT'S GONE INTO THIS, I REALLY WANT TO APPLAUD

THE DILIGENCE AND THE PRODUCT THAT YOU PRODUCED.

THIS IS JUST FANTASTIC. THANK YOU.

DR. MILLAN: THANK YOU.

CHAIRMAN THOMAS: DR. FRIEDMAN AND DEAN

HAWGOOD AND THEN DIANE.

MS. LANSING: CAN I GO AFTER THEM?

CHAIRMAN THOMAS: YOU GOT IT.

DR. FRIEDMAN: AND, SHERRY, IF YOU LIKE,

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I'LL YIELD THE FLOOR TO YOU FIRST IF YOU PREFER.

MS. LANSING: NO. I WANT TO WAIT IN LINE.

DR. FRIEDMAN: OKAY. I TOO WANT TO ECHO

THOSE COMPLIMENTARY REMARKS. I THINK THERE'S A LOT

OF APPEAL HERE. AND IF I CAN, I'LL SHARE 30 SECONDS

WITH YOU OF PERSONAL EXPERIENCE WITH THE CREATION OF

OTHER THERAPEUTIC NETWORKS OVER THE LAST 40 YEARS OR

MORE, MOST ESPECIALLY WATCHING HOW CANCER CLINICAL

TRIALS WERE CONDUCTED AND HOW COOPERATIVE GROUPS

WERE FIRST SET UP AND LEARNING FROM SOME OF THE

INEFFICIENCIES AND THE DYSFUNCTION OF THOSE

ACTIVITIES. CERTAINLY MANY GOOD THINGS WERE

GENERATED, AND I DON'T MEAN TO BE CRITICAL AT ALL.

I SIMPLY WISH TO SAY THAT WE CAN LEARN FROM THOSE

EXPERIENCES, AND THE IDEA OF SETTING UP SOMETHING

LIKE THIS RIGHT NOW AT THIS TIME HAS A LOT OF APPEAL

TO ME.

I THINK THAT THE OTHER THING THAT WE CAN

LOOK TO ARE THE CREATION OF THE HIV CLINICAL TRIAL

NETWORKS AND SOME OF THE LESSONS THAT CAN BE LEARNED

THERE. I THINK THE TIMING ON THIS IS APPROPRIATE.

I THINK THE SCOPE AND SCALE SOUNDS VERY REASONABLE

TO ME. I THINK THAT WE HAVE THE OPPORTUNITY TO

CORRECT SOME THINGS THAT OTHER TECHNOLOGY OR DISEASE

AREAS HAVE FAILED WITH IN THE PAST, SUCH AS SIMPLE

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THINGS LIKE STANDARDIZED DATA FORMS SO THAT

EVERYBODY IS USING THE SAME THING RIGHT FROM THE

BEGINNING, AND YOU DON'T HAVE ALL KINDS OF PROBLEMS

WITH COMPARABILITY AND EXPENSIVE WAYS OF CONVERTING

INFORMATION, OF ESTABLISHING A CULTURE OF

COLLABORATION AND SHARING LEARNINGS BECAUSE EVEN

THOUGH WE WILL BE ALL AROUND THE STATE LOOKING AT

MANY DIFFERENT KINDS OF DISEASES AND TECHNOLOGIES,

ALL THE RESEARCH INSTITUTIONS WILL BE FOCUSING ON

THEIR OWN INDIVIDUAL AREAS. NONETHELESS, I THINK

THERE'S AN OPPORTUNITY FOR A LOT OF CROSS LEARNING

AND LEVERAGING OFF OF THAT, AGAIN, TO SAVE MONEY AND

TO SAVE TIME.

SO WHILE I UNDERSTAND THERE HAS TO BE A

NUMBER OF IMPORTANT DETAILS WORKED OUT HERE, I JUST

WANTED TO SHARE WITH YOU WHY THIS SEEMS, AT LEAST

INTELLECTUALLY, VERY APPEALING TO ME.

DR. MILLAN: THANK YOU.

CHAIRMAN THOMAS: DEAN HAWGOOD.

DR. HAWGOOD: SO I WOULD AGREE WITH THOSE

COMMENTS. JUST A TECHNICAL QUESTION OUT OF

IGNORANCE ON MY PART AROUND THE PROPOSITION. IS

THERE ANY LIMITATION FOR PATIENTS FROM OUTSIDE THE

STATE OF CALIFORNIA RECEIVING TREATMENT UNDER A

CIRM-FUNDED TRIAL?

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AND SECONDLY, BECAUSE SOME OF THESE VERY

CUTTING-EDGE, COMPLICATED PHASE I TRIALS NEED TO

DRAW ON A LARGE GEOGRAPHIC NETWORK, WILL THERE BE AN

OPPORTUNITY FOR COLLABORATIVE SITES OUTSIDE OF

CALIFORNIA IN DELIVERING CARE?

DR. MILLAN: SO FOR THE FIRST QUESTION, I

THINK I'LL DEFER TO JAMES.

MS. BAUM: I'LL ANSWER THAT. IF YOU'RE

ASKING WHETHER OR NOT PATIENTS FROM OUTSIDE OF

CALIFORNIA CAN COME IN, THERE'S ABSOLUTELY NO

PROHIBITION AT ALL.

DR. MILLAN: AND THE SECOND QUESTION ABOUT

CLINICAL NETWORKS, YEAH, AS YOU SAY, IT'S ABSOLUTELY

TRUE THAT ACCRUING PATIENTS FOR SOME OF THESE LATER

PHASE CLINICAL TRIALS CAN BE A HUGE CHALLENGE AND

SHOULD ENGAGE WITH INTERNATIONAL OR NATIONAL AND

ULTIMATELY INTERNATIONAL PARTNERS. SO WITH THE

COLLABORATIVE FUNDING PARTNERSHIP, WE MAY BE ABLE TO

WORK OUT SOME KIND OF ARRANGEMENTS WITH FORMALIZED

AGREEMENTS WITH OTHER CLINICAL SITES OUTSIDE OF

CALIFORNIA. I THINK THE LIMITATION IS THE MONEY

JUST HAS TO BE SPENT WITHIN CALIFORNIA, BUT THERE'S

NOTHING TO LIMIT US FROM ESTABLISHING PARTNERSHIPS

WITH EXTERNAL ENTITIES AS WE ALREADY DO.

DR. HAWGOOD: ONE OTHER COMMENT WHICH I

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THINK SORT OF DOVETAILS OFF MICHAEL'S COMMENT ABOUT

THINKING HARD ABOUT COMMON DATA SETS AND WHATNOT

GOING FORWARD GIVEN THAT NOW MOST OF THE

INSTITUTIONS THAT WILL PROBABLY BE INTERESTED IN

THIS ARE ON ELECTRONIC HEALTH RECORDS, THAT WE TAKE

THAT INTO CONSIDERATION IN THE VERY EARLY PLANNING

STAGES.

CHAIRMAN THOMAS: DIANE.

MS. WINOKUR: I'D LIKE TO COMMENT AS A

NONSCIENTIST, BUT AS A PATIENT ADVOCATE. AND

ACTUALLY FROM MY OWN EXPERIENCE WITH MY OWN PATIENTS

IN CLINICAL TRIALS, THERE IS SUCH A DIVERSITY FROM

ONE SITE TO ANOTHER, DEPENDING ON THE LEADER OF THE

TRIAL, DEPENDING UPON THE INSTITUTION WHERE IT IS,

AND THIS IS FOR THE SAME THERAPY, THIS IS A TRIAL

FOR THE SAME DRUG, WHATEVER. I THINK THAT THE ALPHA

CLINICS WILL BECOME THE MODEL FOR CLINICS THAT ARE

TESTING THINGS UNRELATED TO STEM CELL-RELATED

THINGS. AND THAT WILL IMPROVE THE CLINICAL TESTING

ACROSS THE BOARD.

CHAIRMAN THOMAS: THANK YOU, DIANE.

SHERRY.

MS. LANSING: I JUST WANTED TO SAY THAT I

THINK THIS IS ONE OF THE MOST EXCITING PROPOSALS

THAT WE'VE EVER HAD IN FRONT OF US BECAUSE WAY BACK

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WHEN WHEN WE BEGAN CIRM, THOSE OF US WHO ARE PATIENT

ADVOCATES DREAMED OF THE TIME WHEN CLINICAL TRIALS

WOULD BE THERE TO SAVE LIVES HOPEFULLY OR MAKE

DISEASES -- CHRONIC DISEASES THAT WERE MANAGEABLE.

SO I SEE THE BEGINNING OF THIS DREAM COMING TRUE IN

THESE ALPHA CLINICS. AND I WOULD LIKE TO MOVE THE

ITEM.

CHAIRMAN THOMAS: IT'S BEEN MOVED. BEFORE

WE ACTUALLY TAKE A SECOND, MARCY WOULD LIKE TO

COMMENT, BUT WE'LL TAKE THAT ON ADVISEMENT THERE FOR

ONE SECOND, SHERRY.

MS. LANSING: THANK YOU.

MS. FEIT: AND, AGAIN, I JUST WANT TO

THANK THE STAFF AND DR. TROUNSON FOR THIS CONCEPT.

I HAD AN OPPORTUNITY YESTERDAY TO HEAR IT FOR THE

FIRST TIME; BUT EARLY ON WHEN WE WERE CREATING THE

INSTITUTE, AND JAMES YOU CAN HELP ME HERE, I DON'T

KNOW IF THE PROPOSITION GAVE WORDS TO THE

UNDERSERVED POPULATION OF CALIFORNIA IN THE

DEVELOPMENT OF THERAPIES BECAUSE WE HAD A LOT OF

DISCUSSIONS WHEN WE WERE PUTTING OUR STANDARDS AND

POLICIES TOGETHER REGARDING HOW WE WOULD REACH OUT

TO THOSE POPULATIONS. SO I JUST BRING THAT UP NOW

TODAY IN TERMS OF YOU MENTIONED IN THE PROPOSAL THE

NONPROFIT AND FOR-PROFIT. AND, OF COURSE, YOU KNOW

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THE DIFFERENCE BETWEEN THE TWO IS IN THE NONPROFIT

WE MAKE CONSIDERATIONS FOR THOSE POPULATIONS, AND

MANY TIMES IN THE FOR-PROFITS THEY DON'T. SO I JUST

WANT TO BRING THAT UP.

AND I DON'T KNOW IF THERE WAS LANGUAGE,

JAMES. ORIGINALLY IN THE PROPOSITION, I BELIEVE

THERE WAS BECAUSE WE HAD A GREAT DEAL OF DISCUSSION

IN SETTING UP OUR STANDARDS AND OUR PROTOCOLS TO

REACH OUT TO UNDERSERVED POPULATIONS. BUT GREAT

CONCEPT AND CONGRATULATIONS FOR BRINGING THIS

FORWARD AT THIS TIME.

CHAIRMAN THOMAS: FRANCISCO.

DR. PRIETO: YES. I ALSO REALLY LIKE THIS

IDEA AND WANT TO THANK ALAN AND THE STAFF FOR ALL

THE TIME THEY'VE SPENT DEVELOPING IT AND EXPLAINING

IT TO US. AND THANK MARCY FOR THE COMMENTS SHE JUST

MADE.

THE ONLY QUESTIONS I HAVE, PARTICULARLY IN

LIGHT OF OUR DISCUSSION EARLIER THIS MORNING ARE

ABOUT THE BUDGET. AND I'D LIKE TO UNDERSTAND A

LITTLE BIT MORE ABOUT THAT. PARTICULARLY BECAUSE

THIS IS A LARGE CHUNK OF MONEY, WHAT ARE THE

INCREMENTAL COSTS THAT THE INSTITUTIONS THAT WERE

SUCCESSFUL IN APPLYING WOULD BEAR IN DEVELOPING

SOMETHING LIKE THIS? HOW MUCH SHOULD WE EXPECT THEM

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TO LEVERAGE THE RESOURCES THEY ALREADY HAVE IN

PLACE? I DON'T KNOW IF YOU CAN TELL ME MUCH MORE

ABOUT THAT.

DR. DEWITT: YEAH, WE CERTAINLY CAN. WE

PUT A LOT OF THOUGHT INTO THAT ACTUALLY. AND MAYBE

I'LL JUST TURN THE MIC OVER TO NEIL LITTMAN, WHO DID

THE FINANCIAL MODELING. AND, OF COURSE, THE WAY THE

RFA HAS ALWAYS WORKED, AS YOU KNOW, IS THE

APPLICANTS BRING FORWARD A PROPOSED BUDGET AND PLAN

FOR HOW THEY WOULD MEET THE OBJECTIVES, AND WHAT

THEY COULD LEVERAGE FROM THEIR INSTITUTION WILL BE

AN EXTREMELY IMPORTANT COMPONENT HERE. AS MARIA

POINTED OUT, THE RELATIONSHIP BETWEEN THE CLINIC AND

THE HOSTING INSTITUTION HAS BEEN INTEGRAL. TIGHT

INTEGRATION, THAT WILL DEFINITELY BE AN IMPORTANT

COMPONENT OF WHETHER A PARTICULAR APPLICANT GETS AN

AWARD, HOW MUCH SUPPORT THEY'LL GET FROM THE HOSTING

INSTITUTION.

SO NEIL.

MR. LITTMAN: SO AS NATALIE AND MARIA

INDICATED, IT'S IMPORTANT TO REITERATE THAT OUR

FUNDING WILL NOT BE GOING TO THE DE NOVO DEVELOPMENT

OF NEW INFRASTRUCTURE AND FACILITIES. SO WE FULLY

ANTICIPATE BOTH THE COORDINATING CENTER AND ALPHA

CLINICS WILL USE CIRM FUNDS TO LEVERAGE THEIR

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PREEXISTING INFRASTRUCTURE AND RESOURCES. SO THIS

WILL BE A CRITICAL COMPONENT OF EACH APPLICATION

THAT WE WILL EVALUATE. AND WE'RE ANTICIPATING THAT

20 PERCENT OF THE OVERALL BUDGET, $15 MILLION, WILL

GO TO THE COORDINATING CENTER, 80 PERCENT OF THE

OVERALL BUDGET OR $55 MILLION WILL GO TO THE

ESTABLISHMENT OF UP TO FIVE ALPHA CLINICS.

THE BUDGET FOR EACH OF THESE, IN TERMS OF

THE COORDINATING CENTER, WE BELIEVE THAT IT WILL BE

USED FOR OBVIOUSLY PERSONNEL. IT WILL BE USED TO

CREATE A CENTRALIZED DATABASE THAT COULD ACT AS A

REPOSITORY FOR CLINICAL TRIAL-RELATED INFORMATION.

IT WILL FUND EQUIPMENT AND SUPPLIES FOR THE ALPHA

CLINICS IN ADDITION TO PERSONNEL. WOULD ALSO FUND

EQUIPMENT AND SUPPLIES.

ALSO, IT'S IMPORTANT TO NOTE THAT A

PORTION OF FIXED EXPENSES WILL GO TO THE OVERHEAD

FACILITIES RATES FOR BOTH THE ALPHA CLINICS AND THE

COORDINATING CENTER.

AND I JUST WANT TO MAKE A COMMENT ON

SCALABILITY. YOU KNOW, WE FULLY ANTICIPATE THAT THE

BUSINESS MODEL WILL SCALE OVER THE YEARS. SO

STARTING IN YEAR ONE, NOT ALL THE PERSONNEL MAY BE

FULL TIME DEDICATED TO THE ALPHA CLINICS NETWORK.

AND BY YEAR FIVE WE ANTICIPATE THAT THE PERSONNEL

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WILL PROBABLY GROW IN RELATION TO THE DEMAND AND THE

NUMBER OF CLINICAL TRIALS THAT ARE ACTUALLY BEING

BROUGHT THROUGH THE ALPHA CLINICS NETWORK.

AND THEN JUST IN TERMS OF SUSTAINABILITY,

AS WE MENTIONED, THIS IS A CRITICAL COMPONENT. AND

THIS WILL VERY MUCH DEPEND UPON EACH APPLICANT AND

THEIR EXISTING INFRASTRUCTURE OF HOW MUCH THEY'RE

ABLE TO LEVERAGE THEIR EXISTING INFRASTRUCTURE. SO

THIS IS SOMETHING THAT WE ARE REQUESTING IN THE

BUDGET AND WE WILL EVALUATE VERY CLOSELY BECAUSE

OBVIOUSLY, ONCE CIRM STOPS FUNDING THESE, WE WANT TO

MAKE SURE THAT THESE WILL BE ABLE TO BE FUNDED AND

FINANCIALLY VIABLE FOR THE LONG TERM.

CHAIRMAN THOMAS: DR. BERGLUND.

DR. BERGLUND: I ALSO WANT TO ADD MY

COMMENTS AND CONGRATULATE YOU ON THIS VERY THOROUGH

WORK BEHIND THIS. I THINK THE TIMING, I AGREE WITH

THAT COMMENT, IS ACTUALLY PRETTY GOOD RIGHT NOW

BECAUSE THERE'S BEEN SO MUCH GROWTH IN SOME OF THE

RESOURCES THAT WILL BE USED TO LEVERAGE INTO THIS

PROPOSAL, THAT THIS ACTUALLY CAN FOLD INTO PRETTY

FERTILE GROUND.

I WAS PARTICULARLY PLEASED ACTUALLY TO SEE

THE STRONG EMPHASIS ON THE PUBLIC EDUCATION AND

CONNECTION TO THE PUBLIC. I THINK THAT'S AN AREA

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THAT, ALTHOUGH IT'S RECOGNIZED AT THE NIH LEVEL, I

ACTUALLY FEEL THAT THE NIH FREQUENTLY FALLS PRETTY

SHORT THERE. AND I THINK THIS IS SOMETHING THAT IS

WELL RECOGNIZED HERE AND I THINK ACTUALLY CAN SERVE

AS A MODEL NATIONALLY AS WELL AS THE HEALTHCARE

ECONOMICS.

HAVING BEEN -- THIS IS MY FIRST MEETING.

I'M CURIOUS TO KNOW HOW YOU ARRIVED AT THE NUMBER OF

FIVE SITES. IS THAT SORT OF A CRITICAL MASS

ANALYSIS?

DR. TROUNSON: I'D RATHER HAVE TEN, BUT

YOU HAVE TO WORK THROUGH THE PROCESSES OF WHAT YOU

CAN OFFER IN TERMS OF IT'S A FIVE-YEAR GRANT. IT'S

ABOUT $11 MILLION GOING TO THE CLINICS. SO IT

REALLY CAME OUT, TO BE HONEST, ABOUT FIVE. AND I'M

ALWAYS SORT OF PUSHING THE STAFF WHERE WE COULD HAVE

EIGHT, SIX. AND THEY JUST BRING BACK. THE POINT IS

THAT IF YOU WORK THROUGH THE FINANCES, EVEN ON A

SLIDING SCALE, BEGINNING IN AN AREA BECAUSE WE'RE

ACTUALLY GOING TO HAVE TO GET SOME PEOPLE TRAINED,

THE INDEPENDENT COUNSELORS, FOR EXAMPLE, ARE GOING

TO HAVE TO BE TRAINED BY THE INSTITUTIONS. THIS IS

A REALLY IMPORTANT COMPONENT. BUT IF YOU EVEN PUT

IT ON THAT SLIDING SCALE, YOU CAN'T REALLY GET MORE

THAN FIVE. SO I WILTED UNDER THE PRESSURE OF SAYING

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FIVE THAT WAS ALL AT THIS POINT.

BUT THERE'S A LOT OF INTEREST IN OTHERS

WANTING TO CONNECT TO IT. SO IT MAY BE ABLE TO GROW

REALLY, NOT NECESSARILY BY OUR FUNDING, BUT BY

ATTACHMENT. AND THERE'S A LOT OF INTEREST OUTSIDE

CALIFORNIA, IN TEXAS, OTHER PLACES THAT WANT TO

CONNECT WITH US, AND THE EAST COAST WANTING TO

CONNECT WITH US. AS NATALIE SAID, OUR COLLABORATIVE

FUNDING PARTNERS ARE LOOKING TO SEE WHETHER THIS

MODEL CAN BE UTILIZED OR CAN THEY CONNECT TO IT. SO

I THINK IN DUE COURSE IT MIGHT GROW. AND HOPEFULLY

THAT WILL GROW WITH APPROPRIATE FUNDING COMING FROM

OTHER SOURCES.

CHAIRMAN THOMAS: DIANE, THEN DEAN

BRENNER.

MS. WINOKUR: DO YOU ENVISION A SPECIAL

ROLE FOR THE BRICK AND MORTAR STEM CELL RESEARCH

CENTERS THAT WE'VE ESTABLISHED HERE IN CALIFORNIA?

DR. DEWITT: WELL, YEAH. I THINK THAT'S

AN INTEGRAL PART OF IT BECAUSE THAT'S WHERE THESE

INVESTIGATIONAL THERAPIES ARE BEING DEVELOPED. AND

MANY OF OUR GRANTEES ON THE DISEASE TEAMS ARE HOUSED

IN THESE FACILITIES. AND SO WE -- I MEAN WE DIDN'T

EMPHASIZE THAT VERY MUCH IN THIS PRESENTATION, BUT

THOSE TEAMS OF RESEARCHERS ARE REALLY INTEGRAL, AND

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WE EXPECT THAT THEY'LL BE PART OF THE FIRST WAVE OF

THERAPIES THAT ARE BEING TESTED AND APPROVED. SO,

YEAH, I THINK THAT THIS BUILDS ON, THIS VERY MUCH

BUILDS ON WHAT HAS ALREADY BEEN ESTABLISHED BY CIRM.

SO IT'S A VERY NICE CONTINUITY TO THAT.

DR. TROUNSON: I WOULDN'T NECESSARILY

THINK THAT THESE CLINIC FACILITIES WILL BECOME PART

OF THE STEM CELL INSTITUTES BECAUSE THEY REALLY

HOUSE RESEARCHERS. BUT MY FEELING, LOOKING AROUND,

IS THAT THERE ARE FACILITIES THAT ARE BEING

DEVELOPED WHICH WOULD ABSOLUTELY SORT OF FIT THIS

BILL EXTREMELY WELL. SO THE RESEARCHERS WILL BE AT

THOSE INSTITUTES, BUT THE FACILITIES, I THINK, WILL

BE IN THE MEDICAL CENTERS AND THE APPROPRIATE AREAS.

AND I KNOW AT THE DIFFERENT INSTITUTIONS AND SO ON,

THEY'VE GOT THESE KIND OF THINGS IN THOUGHT IF NOT

ALREADY IN EVOLUTION.

CHAIRMAN THOMAS: DEAN BRENNER AND THEN

AL.

DR. BRENNER: SO I ASSUME ONE OF THE GOALS

IS TO HAVE SITES WHERE YOU CAN HAVE A DISEASE TEAM

PROGRESS AND ACTUALLY DO TRIALS. BUT I SUSPECT THAT

SEVERAL DISEASE TEAMS WILL NOT DEVELOP CELL

THERAPIES PER SE. THEY'LL DEVELOP SMALL MOLECULES

BASED UPON USING STEM CELLS. AND I JUST WANT TO

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MAKE SURE THAT WE INCLUDE -- I WOULD RECOMMEND THAT

WE INCLUDE THEM IN THIS PROPOSAL.

DR. DEWITT: THAT WASN'T -- ACTUALLY WE

DID DEFINE THE SCOPE DIFFERENTLY, WHICH WAS THE

SCOPE WOULD BE LIMITED TO STEM CELL-BASED PRODUCTS

THAT WOULD BE CELLULAR IN NATURE. AND THE REASON

FOR THAT IS THAT THOSE TYPES OF PRODUCTS HAVE VERY

DIFFERENT REQUIREMENTS FOR TESTING. SO WE REALLY

WANTED TO BE SURE THAT THOSE RESOURCES ARE PUT INTO

PLACE TO MEET THOSE SPECIFIC NEEDS THAT WE FEEL ARE

UNMET.

THE BIOLOGICS AND THE SMALL MOLECULES,

THERE'S ALREADY PRETTY GOOD INFRASTRUCTURE AND

KNOWLEDGE BASE, BUT CERTAINLY I WOULDN'T WANT TO SEE

ANYTHING INTERESTING EXCLUDED IN TERMS OF PUTTING

THAT DATA INTO THE DATABASE AND HAVING

PARTICIPATION. BUT REALLY THE FOCUS IS GOING TO BE

MORE ON CELL-BASED THERAPIES JUST SIMPLY BECAUSE WE

HAVE LIMITED RESOURCES AND THAT'S THE AREA OF

GREATEST NEED.

DR. BRENNER: THAT COULD BE KIND OF A PURE

VICTORY IF WE SPENT $20 MILLION ON A DISEASE TEAM

AND THE PRODUCT THEY CAME UP WITH WAS A SMALL

MOLECULE, THEN WE DIDN'T HELP THEM CONTINUE WITH IT.

DR. DEWITT: YEAH. THAT'S A GOOD POINT.

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DR. TROUNSON: DAVID, I THINK I AGREE WITH

NATALIE HERE. BUT THERE ARE A LOT OF COMBINATION

THERAPIES THAT ARE GOING TO EVOLVE, AND THEY'RE

GOING TO EVOLVE WITH CELLS AND WITH SMALL MOLECULES,

TO BE HONEST. AND I THINK THAT WILL BE READILY

INCORPORATED INTO THIS. AND, OF COURSE, THINGS LIKE

GENETICALLY ENGINEERING CELLS TO PRODUCE CURES FOR

GENETIC DISEASE OR PREVENTION OF HIV, THEY'RE ALL

INCLUDED.

I THINK WE DIDN'T WANT TO DUPLICATE THE

CAPACITY THAT THERE IS WITH THE CONVENTIONAL

THERAPIES. WE WANTED TO SAY THIS IS SPECIAL. THIS

IS GOING TO BE DIFFERENT. YOU'RE GOING TO TAKE YOUR

CELLS AND WE'RE GOING TO HAVE TO WORK WITH THAT, AND

THAT'S WHAT'S REALLY DIFFERENT. I MEAN I THINK WE

NEED TO LOOK AT OTHER MECHANISMS, IF NEEDS BE, TO

MAKE SURE THE POINT THAT YOU'RE MAKING, THEY'RE

ACCOMMODATED, BUT I GOT THE FEELING THAT THEY WILL

BE ACCOMMODATED, BUT WE'LL KEEP A VERY CLOSE EYE ON

THAT.

CHAIRMAN THOMAS: MR. ROWLETT.

MR. ROWLETT: THANKS VERY MUCH. I

APPRECIATE THE PRESENTATION AS A NEW BOARD MEMBER

AND I TRY TO NAVIGATE ALL THIS. HOPEFULLY MY

QUESTIONS WILL MAKE SENSE TO YOU FOLKS.

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FIRST, AS SOMEONE SAID, FOR THE

UNDERSERVED COMMUNITIES, OFTENTIMES THE RELATIONSHIP

BETWEEN THE PAYER AND THE PATIENT IS IMPORTANT. SO

MY ASSUMPTION IS THAT CONSIDERATION HAS BEEN GIVEN

TO MEDICAID AND OTHER PROVIDERS, THAT THEY WILL PAY

FOR THE THERAPIES THAT WILL BE PROVIDED AT THE ALPHA

CLINICS.

DR. DEWITT: WELL, UNFORTUNATELY THAT

HASN'T BEEN ESTABLISHED YET BECAUSE THOSE

ORGANIZATIONS NEED MANY YEARS OF DATA, LIKE, I THINK

FOUR YEARS OF DATA, TO AGREE. SO WE WILL HAVE AT

THE CIMC STAFF IN PLACE THAT WILL TRY TO ACCELERATE

THAT PROCESS AND WILL HAVE THE REPOSITORY FOR DATA

THAT WILL INFORM THAT PROCESS. AND WE WANT FROM THE

VERY BEGINNING FOR THIS NETWORK TO BE CONNECTED WITH

THE ORGANIZATIONS THAT ARE TRYING TO ACCELERATE THE

AGREEMENT OF MEDICARE, MEDICAID, AND SO ON TO PAY

FOR THIS. OTHERWISE IT'S HARD TO IMAGINE HOW ANY OF

THIS WILL BE SUSTAINABLE AND CAN BE DELIVERED TO

PATIENTS. SO THAT'S A REALLY CRITICAL PART.

MR. ROWLETT: FOR THE MEMBERS OF THE BOARD

AND THE CHAIR, AS THE CONVERSATION RELATED TO

SUSTAINABILITY HAS COME UP SEVERAL TIMES, I THINK

THAT IF THERE'S A WAY TO MORE FORMATIVELY ESTABLISH

THAT RELATIONSHIP SOONER, YOU SHOULD DO THAT BECAUSE

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I DON'T KNOW HOW -- IT'S A GREAT CONCEPT, BUT

OFTENTIMES, AS SOMEONE SAID EARLIER, GREAT CONCEPTS

DON'T COME TO FRUITION BECAUSE THAT HASN'T BEEN

TAKEN INTO CONSIDERATION IN THE BEGINNING.

DR. MILLAN: SO THE CONSIDERATIONS

REGARDING REIMBURSEMENT AND HEALTHCARE COST COVERAGE

WERE DEFINITELY A TOPIC THAT WAS INTEGRAL TO OUR

DISCUSSIONS. AND WE HAVE ACTUALLY BROUGHT IN SOME

EXTERNAL EXPERTISE TO HAVE THESE DISCUSSIONS. THAT

WILL BE A COMPONENT IN TERMS OF STATING SPECIFIC

PROGRAMS. AT THIS TIME I THINK THERE'S STILL SOME

GROUNDWORK THAT NEEDS TO BE DONE, AND THE IDEA IS

THE CIMC WOULD BE ABLE TO ASSEMBLE THE CRITICAL

EXPERTISE TO BE ABLE TO START FORMING THOSE SYSTEMS

AND THOSE APPROACHES. SO IT IS ANTICIPATED, EVEN IF

IT'S NOT FORMALLY STATED IN THIS CONCEPT.

CHAIRMAN THOMAS: DR. STEWARD.

DR. STEWARD: SO THE DETAILS OF THIS WERE

A LITTLE, I GUESS, SURPRISING TO ME, BUT THAT'S JUST

BECAUSE I PROBABLY DIDN'T PAY ENOUGH ATTENTION

COMING FORWARD. AND BY THAT I MEAN THE REQUIREMENT

THAT THE SITES BE READY TO START A CLINICAL TRIAL

WITHIN 12 MONTHS. AND I BRING THAT UP NOW BECAUSE I

HAD SORT OF ENVISIONED THIS AS SEARCH FOR THE VERY

BEST SITES FOR THESE KINDS OF OPERATIONS REGARDLESS

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OF WHERE THEY WERE ALONG THE TIMELINE.

I UNDERSTAND WHY YOU MIGHT WANT TO DO

THAT, BUT MY SPECIFIC QUESTION THEN BECOMES WHAT IF

THAT CLINICAL TRIAL DOESN'T GO FORWARD? THINGS

HAPPEN.

DR. DEWITT: I THINK I'LL TAKE -- I'LL

JUST TAKE A FIRST STAB AT THAT. THE IDEA BEHIND

THAT ELIGIBILITY CRITERIA IS THAT WE DO FEEL THAT

THERE IS ALREADY A NEED FOR THESE TYPES OF SYSTEMS

TO BE PUT IN PLACE AND THESE RESOURCES, AND THAT

CAME FROM THE NEED ANALYSIS AND THE GAP ANALYSIS.

IN ORDER WITHIN A TIME YEAR, THE FIVE-YEAR

TIME FRAME, IN ORDER TO GET THIS SYSTEM UP AND

RUNNING, OPERATIONAL AND GET EVERYTHING GOING, WE

REALLY DO NEED ACTIVITIES WITHIN THE CLINICS. SO

WHEN THESE APPLICANTS COME FORWARD FOR THE ALPHA

CLINIC RFA, THEY WOULD BRING THEM WITH A LEAD

PROJECT, AT LEAST ONE LEAD PROJECT, POSSIBLY TWO.

AND THEY WOULD BE EVALUATED BASED ON THE STRENGTH OF

THEIR INSTITUTION, THEIR TRACK RECORD, AND ALL THE

COMPONENTS THAT WERE LAID OUT IN THE ELIGIBILITY AND

SCOPE SLIDE.

BUT IN ADDITION, THE PROJECT THAT THEY

BRING FORWARD WILL BE EVALUATED REGARDING ITS

STRENGTH, AND THERE WILL BE THE REQUIREMENT TO

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PROVIDE EVIDENCE THAT THIS IS SOMETHING THAT'S

ALREADY AN ESTABLISHED RELATIONSHIP, WHETHER IT WAS

CATALYZED BY THIS RFA OR WHETHER IT WAS ALREADY

PLANNED, AND WHAT THE TIMELINE ON THAT LOOKS LIKE

AND HOW FEASIBLE IT REALLY WOULD BE TO INITIATE THAT

TRIAL WITHIN THE 12-MONTH PERIOD.

DR. STEWARD: THANKS. I DO APPRECIATE

THAT, BUT THERE'S STILL THE QUESTION THINGS HAPPEN,

AND WHAT HAPPENS IF THAT TRIAL DOESN'T GO FORWARD?

DR. FEIGAL: HERE'S WHAT I WOULD SUGGEST.

SO WHAT WE'RE GOING TO DO, AT LEAST AS A FIRST PASS,

WE WANTED TO MAKE SURE THESE UNITS COULD HIT THE

GROUND RUNNING. SO THERE HAD TO BE SOMEWHERE IN THE

DENOMINATOR AT LEAST THE POSSIBILITY THAT THERE

WOULD BE CLINICAL TRIALS THAT WOULD ENTER INTO THIS

CLINICAL INFRASTRUCTURE. AND, OF COURSE, STUFF

HAPPENS. SO WE'LL DEAL WITH REALITY.

BUT THE OTHER ISSUE, I DO WANT TO BE

CLEAR, IS IT'S RECEPTIVE AND IT'S OPEN TO CONTINUING

INFLUX OF NEW TRIALS, THAT JUST WHAT COMES IN THE

INITIAL BATCH IS NOT THE FINAL BATCH. SO WE EXPECT

THERE'S GOING TO BE A LOT OF SETUP. THERE'S GOING

TO BE A LOT OF ISSUES THAT WILL NEED TO BE ADDRESSED

AND THAT TRIAL WILL COME IN.

WE ARE CONTINUING AS PART OF OUR STRATEGIC

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PLAN TO FUND SCIENTIFICALLY SOUND PRECLINICAL AND

IND-ENABLING CLINICAL TRIALS TO GO FORWARD. SO

SEPARATE FROM CLINICAL INFRASTRUCTURE, CIRM IS GOING

TO CONTINUE, IF THE BOARD AGREES, WITH CONTINUING TO

FUND THESE GREAT IDEAS COMING IN, WHICH WILL PROVIDE

SOME OF THE FODDER FOR WHAT COULD GO INTO THIS

CLINICAL INFRASTRUCTURE. WE'LL CONTINUE TO FUND

THAT SEPARATELY. SO, YOU KNOW, THIS IS REALLY THE

COMPLEMENTARY PIECE OF WHAT WE KNOW ARE GAPS, ACCESS

TO CONSULTATIVE EXPERTISE IN BIOSTATISTICS AND HOW

TO NAVIGATE THE REGULATORY PATHWAY, IN METHODOLOGY,

AND HOW TO PUT TOGETHER A CLINICAL TRIAL WITH

APPROPRIATELY DEFINED ENDPOINTS TO ACTUALLY ANSWER

THE QUESTION, AND ALSO CONNECT PEOPLE TO THE OTHER

APPROPRIATE NETWORKS SO THAT THEY CAN ENROLL.

SO WE THOUGHT AT A MINIMUM WE NEEDED TO

HAVE SOME LEVEL OF ACTIVITY TO SUPPORT PUTTING AN

INFRASTRUCTURE INTO PLACE NOW. AND WE THINK FROM

OUR OWN ANALYSIS WE DO HAVE THE TRIALS THAT,

BARRING, AS YOU SAID, UNEXPECTED THINGS HAPPENING,

THAT WE WILL BE ABLE TO HAVE THAT AT LEAST THRESHOLD

LEVEL OF ACTIVITY TO JUSTIFY PUTTING THIS CLINICAL

INFRASTRUCTURE IN PLACE.

CHAIRMAN THOMAS: DR. DULIEGE.

DR. DULIEGE: YES. AND ACTUALLY EXACTLY

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ALONG THIS PATH, I THINK ONE OF THE MANY CRITICAL

COMPONENTS OF THIS PLAN THAT YOU HAVE OUTLINED IS

THE REGULATORY SUPPORT. CLEARLY BECAUSE,

PARTICULARLY IN THE NONPROFIT ENVIRONMENT, THE

KNOWLEDGE OF THE REGULATORY PATH FORWARD AND THE

CHALLENGES ARE SIGNIFICANT. AND EVEN ON THE FDA

SIDE, I'M SURE THE FDA THEMSELVES HAVE A TON OF

QUESTIONS ON HOW THEY SHOULD DIRECT THE REGULATORY

ENVIRONMENT IN THIS LARGELY UNCHARTERED PATH AND

WOULD NEED SOME LEVEL OF COLLABORATION ESSENTIALLY

WITH EDUCATION. SO THAT'S REALLY, I SEE, ONE OF THE

KEY FUNCTIONS OF THIS.

I WANT TO CONGRATULATE, TOGETHER WITH MY

COLLEAGUES, THE STAFF FOR THIS VISION HERE.

DR. FEIGAL: I ACTUALLY JUST WANT TO MAKE

A COMMENT. WHEN THE FDA HEARD THAT WE WERE PUTTING

THIS CONCEPT TOGETHER, THEY CALLED ME TO FIND --

THEY WERE QUITE -- VERY EXCITED, VERY INTERESTED

THAT WE WERE TRYING TO PUT TOGETHER A VERY RIGOROUS,

A CERTAIN LEVEL OF QUALITY THAT WOULD GO INTO THE

CLINICAL TRIAL. SO ACTUALLY THEY GOT WIND OF WHAT

WE WERE THINKING ABOUT AND WERE QUITE INTERESTED IN

WHAT WE WERE DOING.

CHAIRMAN THOMAS: I HAVE A QUESTION HERE.

ON THE SORT OF THEORY THAT IF WE BUILD THEM, THEY

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WILL COME, ARE WE GOING TO REQUIRE IN ANY WAY THAT

FUNDED PROJECTS GOING FORWARD UTILIZE THE ALPHA

CLINIC NETWORK? AND I ASK THAT BECAUSE, IN THEORY

AT ANY RATE, THIS WILL BE THE STATE-OF-THE-ART WAY

TO GO AND PEOPLE WILL FLOCK TO IT. ON THE OTHER

HAND, YOU MAY HAVE SITUATIONS WHERE THEY DECIDE TO

RUN CLINICAL TRIALS AT THEIR OWN INSTITUTION OR

WHATEVER. I GUESS THE QUESTION IS HOW ARE WE

COMFORTABLE THAT THESE WILL BE UTILIZED?

DR. TROUNSON: JON, MY VIEW WOULD BE TO

ENCOURAGE, BUT NOT REQUIRE. WHERE IT MAKES GOOD

SENSE, ABSOLUTELY; BUT SOME INSTITUTIONS WHO ARE NOT

PART OF THE NETWORK MAY WISH TO DO THAT SEPARATELY.

BUT ALSO OUTSIDE OUR OWN PROGRAMS WE EXPECT CLINICAL

TRIALS TO BE COMING IN THAT ARE NOT FUNDED

SPECIFICALLY BY US AS WELL. SO WE THINK AS MUCH

FLEXIBILITY AS POSSIBLE, BUT WITH GOOD

ENCOURAGEMENT, BUT NOT REQUIRE.

CHAIRMAN THOMAS: MR. SHEEHY.

MR. SHEEHY: I THINK SHERRY'S MOTION IS

DANGLING WITHOUT A SECOND, SO I'D LIKE TO OFFER THAT

SECOND NOW.

CHAIRMAN THOMAS: MOTION MOVED AND

SECONDED.

MS. SAMUELSON: AND I HAVE A COMMENT AND A

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FRIENDLY AMENDMENT.

CHAIRMAN THOMAS: YES, JOAN.

MS. SAMUELSON: COMING IN FROM LEFT FIELD,

BUT -- AND THAT WOULD BE THAT THERE BE AN ASSESSMENT

OF THIS PLAN BY THE GRANTS WORKING GROUP WITH A

RECOMMENDATION TO THE BOARD BEFORE WE TAKE A FINAL

VOTE.

AND HERE'S WHY I SAY THAT. SITTING ALL

THESE YEARS ON THAT WORKING GROUP AND LOOKING AT THE

PROPOSALS COMING IN THE DOOR, AND LORD KNOWS THESE

ARE EXTREMELY BRIGHT SCIENTISTS WORKING VERY HARD

AND WANTING VERY BADLY TO DO THE BEST BY THEIR

PATIENTS, AND THEY BY AND LARGE FAIL BECAUSE THE

SCIENCE ISN'T THERE YET. MAYBE IT COULD BE IF WE

WERE FOCUSING MORE ON THE TRANSLATIONAL PIECE.

WE BIT OFF A BIG JOB WHEN WE STARTED

IMPLEMENTING PROP 71, AND THIS I SEE IS THE

CULMINATION OF THAT WITH ALL THE ELEMENTS OF IT.

BUT WE HAVEN'T DONE THE ESSENTIAL WORK TO GET THE

BEST POSSIBILITY TO GET ACTUAL FINISHED, EFFECTIVE

THERAPIES OUT THE DOOR WITH THE MONEY WE HAVE LEFT.

AND SO TO DO ALL OF THIS INFRASTRUCTURE

AND BUREAUCRACY AND COMMUNICATIONS AND SO ON, IT

SEEMS PREMATURE BECAUSE WE DON'T HAVE INFINITE

MONEY. AND I DON'T SEE US ABLE TO PRODUCE WHAT

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PEOPLE REALLY WANT FROM THAT SPENDING, WHICH IS TO

HAVE EFFECTIVE THERAPIES FOR, FOR EXAMPLE, THE

NEURODEGENERATIVE DISORDERS. THEY'RE TRYING. THEY

SUBMIT DISEASE TEAM GRANTS AND TRANSLATIONAL GRANTS

AND THEY FAIL. THEY GET LOW SCORES BECAUSE THEY'RE

DEEMED TOO RISKY. THERE'S NOT ENOUGH DATA.

AND SO I GUESS I QUESTION WHETHER THIS IS

GETTING US WHAT WE REALLY WANT FOR THE COMMUNITY OF

SICK AMERICANS AND CITIZENS OF THE WORLD WHO WANT TO

GET REGENERATIVE MEDICINE TO DELIVER SOMETHING

EFFECTIVE. THEY DON'T CARE IF IT'S A BRAND-NEW

THERAPY OR NOT. THEY WANT SOMETHING EFFECTIVE.

THERE ISN'T ANYTHING NOW. THERE ISN'T ANYTHING FOR

PEOPLE WITH PARKINSON'S. THEY'RE STRUGGLING

TERRIBLY AND DYING, AND THAT'S TRUE OF MANY OF THE

NEURODEGENERATIVE DISORDERS AND, OF COURSE, LOTS OF

THE OTHERS. AND OUR CURRENT AND RECENT HISTORY WITH

CLINICAL TRIALS TO DATE SUGGESTS THAT THERE'S NOT

GOING TO BE A LOT OF OPTIONS AT THE DOOR FOR THE

PEOPLE WHO COME AND LINE UP.

CHAIRMAN THOMAS: CAN I JUST RESPOND TO

THAT? I THINK, JOAN, THANK YOU FOR YOUR POINTS.

THIS IS A CONCEPT PROPOSAL. I'M NOT SURE IF YOU'RE

SUGGESTING THAT THE CONCEPT PROPOSAL BE SUBJECTED TO

GRANTS WORKING GROUP REVIEW BECAUSE THAT'S NOT

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HISTORICALLY HOW WE HAVE DONE THAT. THIS IS --

MS. SAMUELSON: I KNOW. IT IS AN OPTION.

WELL, IT'S ONE OF THE TASKS OF THE WORKING GROUP

THAT'S SPECIFIED IN THE LAW. WE HAVE NEVER

IMPLEMENTED IT. I'VE ALWAYS WANTED TO BECAUSE

THERE'S IMMENSE EXPERTISE BY THAT GROUP FROM THE

MANY YEARS OF LOOKING AT THE GRANT PORTFOLIO, BUT I

KNOW WE HAVEN'T DONE THAT.

CHAIRMAN THOMAS: DR. TROUNSON AND THEN

MR. SHEEHY.

DR. TROUNSON: WELL, I THINK, OF COURSE,

THE PROPOSALS ARE GOING TO GO IN FRONT OF THE GRANTS

WORKING GROUP AS THEY NORMALLY DO. AND SO THEY WILL

HAVE REAL OPPORTUNITY TO INPUT AT THAT POINT, AND

THEY NEED TO SELECT THE APPROPRIATE OR SELECT NONE

AS HAS BEEN DONE SOMETIMES IN THE PAST. SO I THINK

THAT'S THE APPROPRIATE WAY TO PROCEED, IF I MAY

SUGGEST.

MS. SAMUELSON: COULDN'T OUR SURPLUS

MEMBERS, WE'VE GOT OVER A HUNDRED MEMBERS OF THE

GRANTS WORKING GROUP.

DR. TROUNSON: YEAH. BUT WE DON'T

NORMALLY BRING A HUNDRED MEMBERS TO EACH GRANT

REVIEW. SO THAT WILL BE FOCUSED ON CLINICAL. WE

WILL SELECT THOSE PEOPLE WHO HAVE GOT THE EXPERTISE,

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AND WE'LL BRING MEMBERS HOPEFULLY TO THE BOARD HERE

TO COMPLEMENT THOSE PEOPLE THAT ARE THERE WHO HAVE

GOT REAL EXPERTISE IN THIS PARTICULAR AREA. SO I DO

THINK IT'S THE WAY TO PROGRESS.

AND I THINK ELLEN MIGHT WANT TO MAKE A

COMMENT, BUT WE HAVE A STEERING COMMITTEE OF

THOSE -- OF THE KEY PEOPLE FROM THOSE CLINICS WHO

ARE GOING TO BE ON THE STEERING COMMITTEE OF THE

CENTRAL CORE. SO YOU KNOW THAT'S GOING TO HAPPEN.

AND WE WILL ACTUALLY ALSO HAVE MILESTONES FOR WHICH

WE WILL REVIEW, AND WE WILL PUT THAT THROUGH THE

APPROPRIATE REVIEW. IF IT'S CDAP OR SOME OTHER

APPROPRIATE REVIEW, WE WILL DO THAT.

SO I THINK IT'S REASONABLY WELL FORMATTED

AS IT IS, IF I MAY SUGGEST.

MR. SHEEHY: I JUST WANTED TO MAKE ONE

COMMENT BECAUSE I THINK THIS WILL KIND OF ADDRESS

JOAN'S KEY CONCERN. AND YOU KIND OF ILLUSTRATED IT

WITH THE VIDEO. DR. WAGNER IS ON OUR WORKING GROUP.

SO I THINK THE PIECE OF THIS THAT YOU'RE MISSING,

JOAN, IS WHAT TOOK PLACE AT THE WORKSHOP. AND

AGAIN, SO MUCH CREDIT TO STAFF FOR ALL THEIR HARD

WORK. THE KIND OF SCIENTIFIC EXPERTISE THAT YOU

WANTED TO BRING TO BEAR FROM THE GRANTS WORKING

GROUP ON THIS CONCEPT HAS ACTUALLY BEEN DELIVERED IN

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THE DEVELOPMENT OF THE CONCEPT, WHICH INCLUDED --

YOU KNOW, YOU GUYS MAY KNOW HOW MANY PEOPLE FROM THE

GRANTS WORKING GROUP ARE ACTUALLY PART OF THIS

PROCESS, BUT THERE WERE A NUMBER OF -- THE

SCIENTIFIC FIREPOWER, I THINK, IF I'M CORRECT, WAS

INCREDIBLY IMPRESSIVE AND DID INCLUDE MEMBERS OF THE

GRANTS WORKING GROUP.

CERTAINLY DR. WAGNER FOR THIS STAGE OF

MEDICINE IS ONE OF THE TOP EXPERTS IN THE WORLD AND

CERTAINLY THE TYPE OF PERSON YOU'D WANT TO HAVE

WEIGH IN ON THIS.

SO WITH ALL DUE RESPECT, I APPRECIATE YOUR

CONCERN, BUT I ACTUALLY THINK THAT STEP HAS BEEN

TAKEN AND THAT THAT WORKSHOP WAS REALLY WHERE THE

KIND OF DEEP THINKING THAT YOU WERE HOPING WOULD

HAPPEN WOULD TAKE PLACE. AND THE FAILURES THAT

YOU'RE ALLUDING TO IN OUR ABILITY TO MOVE THINGS

INTO THE CLINIC, I THINK THIS WILL ADDRESS IT. THIS

IS PRECISELY THE TYPE OF INITIATIVE THAT CAN REALLY

TACKLE THAT GAP.

MS. SAMUELSON: BY ACTUALLY MOVING FOR ALL

THE DISEASES THAT ARE TARGET DISEASES, MOVING THE

STATE OF THE ART TO A PLACE WHERE THEY'RE READY?

MR. SHEEHY: IT CREATES AN INFRASTRUCTURE

SO THAT EVERYBODY WHO WANTS TO TRY TO MOVE A PROJECT

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INTO THE CLINIC CAN REALLY JUST GO AND TAP INTO

SOMETHING. YOU KNOW, HOW MANY TIMES HAVE THINGS

FAILED BECAUSE THEY DON'T HAVE THE RIGHT ANIMAL

MODEL, THEY DON'T HAVE THE PRODUCTION TO MAKE THE

CELLS? I MEAN YOU CAN JUST GO DOWN THE LIST OF THE

THINGS THAT PEOPLE, AGAIN, RETURN TO WITHIN THE

REVIEW THAT MAKE THE PROJECT A CHALLENGE, AND A LOT

OF THESE THINGS ARE CORE FEATURES OF THE CLINICS AND

OF THE CENTRAL COORDINATING CENTER. HAVING ALL THAT

AVAILABLE TO AN INVESTIGATOR WHO HAS A GREAT IDEA,

HAS SOME GREAT DATA, AND IS READY TO START MOVING

TOWARDS THE CLINIC IS GOING TO HELP THAT INDIVIDUAL

PRODUCE A PROJECT THAT WILL GET MUCH HIGHER SCORES

IN OUR WORKING GROUP THAN WHAT THEY MIGHT GET

WITHOUT THAT BEING IN PLACE.

CHAIRMAN THOMAS: INDEED, JOAN, I WOULD

SAY THAT WITHOUT A PROGRAM LIKE THIS IN PLACE, YOU

WOULD NOT BE ABLE TO ADVANCE THE BALL PRECISELY IN

THE MANNER THAT YOU HOPED TO ACHIEVE. SO I THINK

THIS IS A CRITICAL ELEMENT OF THE WHOLE GAME PLAN.

DR. VUORI.

DR. VUORI: I WOULD LIKE TO ECHO EXACTLY

THAT POINT, THE POINT THAT J.T. AND JEFF MADE, THAT

THIS ALPHA CLINIC CONCEPT IS ABSOLUTELY CRUCIAL IN

NOT ONLY TESTING THE THERAPIES THAT ARE ABOUT TO

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COME AND ARE ON THE CUSP IN MOVING TO THE PATIENTS,

BUT ALSO LEARNING HOW IS IT THAT WE REALLY APPLY THE

STEM CELL TECHNOLOGIES IN HUMAN BEINGS AND IN THE

CLINIC. AND CIRM IS IN A VERY UNIQUE POSITION TO DO

JUST THAT, SPEARHEAD AND LEAD THOSE EFFORTS IN

IDENTIFYING THE ABSOLUTE BEST WAYS AND PROCESSES FOR

IMPLEMENTING THESE THERAPIES IN HUMAN BEINGS AND

WORKING WITH FDA AND PROBABLY BECOME REALLY A LEADER

IN THIS AREA IN A VERY, VERY UNIQUE MANNER.

CHAIRMAN THOMAS: OKAY. I GUESS THE

QUESTION IS -- YES, WE'RE GOING TO HAVE MEMBERS OF

THE PUBLIC IN ONE SECOND. JUST WITH RESPECT TO THE

MOTION, JOAN, DO YOU STILL WANT TO ASK THAT THERE

STILL BE A FRIENDLY AMENDMENT, OR ARE YOU OKAY?

MS. SAMUELSON: I CAN'T VOTE FOR THIS

WITHOUT THAT, SO I WOULD LIKE TO DO THAT. IF IT'S

ONE VOTE FOR IT, MAYBE YOU COULD SKIP THAT.

CHAIRMAN THOMAS: I GUESS THE PROPER --

MS. SAMUELSON: WITH THE LIMITED POT, I'M

JUST NOT -- THAT'S THE OTHER QUESTION REALLY. HOW

MUCH MONEY WOULD BE LEFT AFTER WE USE THIS MONEY FOR

THIS STEP --

CHAIRMAN THOMAS: WELL, I THINK WE

HEARD --

MS. SAMUELSON: -- TO CONTINUE TO

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DO -- I'M SORRY. EXCUSE ME, J.T. -- THE PORTFOLIO

OF TRANSLATIONAL GRANTS THAT WOULD FEED THE MOVEMENT

OF THE SCIENCE AS OPPOSED TO INFRASTRUCTURE?

CHAIRMAN THOMAS: I THINK WE HEARD EARLIER

FROM DR. OLSON THAT IF WE GET THROUGH THE THREE

CONCEPT PROPOSALS HERE, THERE WOULD STILL BE A

LITTLE LESS THAN 600 MILLION LEFT IS THE ANSWER TO

THAT QUESTION.

OKAY. MR. HARRISON, DO I -- IS THE PROPER

PROCEDURE HERE TO ASK SHERRY AS THE MOVER WHETHER

SHE WOULD ENTERTAIN THAT FRIENDLY AMENDMENT?

MS. LANSING: I'M VERY CONFUSED, SO YOU

HAVE TO EXPLAIN TO ME WHAT THE AMENDMENT IS.

MS. SAMUELSON: HI, SHERRY. THE AMENDMENT

WOULD SEEK AN ASSESSMENT OF THIS PLAN BY THE GRANTS

WORKING GROUP AND WITH A RECOMMENDATION TO THE BOARD

BEFORE A FINAL VOTE.

MS. LANSING: EVERYTHING WOULD GO FORWARD

AND THERE WOULD BE ONE ADDITIONAL STEP?

MS. SAMUELSON: NO. THAT WOULD BE PART OF

THE DECISION-MAKING ON WHAT WE VOTE ON.

CHAIRMAN THOMAS: SHE'S RECOMMENDING WE

DEFER CONSIDERATION OF THIS PENDING REVIEW OF THE

CONCEPT BY THE GRANTS WORKING GROUP.

MS. LANSING: MEANING DEFER CONSIDERATION

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TODAY?

MS. SAMUELSON: YEAH.


MS. LANSING: I LOVE YOU, JOAN, AND I

ALWAYS WANT TO SUPPORT WHAT YOU'RE SAYING, BUT I'M

PREPARED TO VOTE ON THIS TODAY. SO I GUESS I WOULD

ASK THE OTHER BOARD MEMBERS, IF NO ONE ELSE BUT

ME -- I'M PREPARED TO VOTE APPROVAL FOR THIS TODAY.

I THINK IT'S GREAT. AND I HAVE BEEN FOLLOWING IT

ALL THROUGH THE PHONE VERY GOOD. EVERYONE TALKED

VERY LOUDLY. SO IF OTHER PEOPLE ARE NOT

COMFORTABLE, I THINK YOU SHOULD TAKE A VOTE AND SEE

WHO'S PREPARED TO DO IT TODAY. SO I WOULD ASK FOR

THIS. AND IF IT DOESN'T PASS, THEN LET'S PUT JOAN'S

FORWARD.

CHAIRMAN THOMAS: OKAY.

MS. SAMUELSON: SOUNDS GOOD.

CHAIRMAN THOMAS: MR. SHEEHY, AS THE

SECONDER OF THE MOTION, A COMMENT?

MR. SHEEHY: YEAH. I THINK -- AND AGAIN,

THIS IN NO WAY DIMINISHES MY ENORMOUS ADMIRATION FOR

YOU, JOAN, BUT --

MS. LANSING: I WANT TO SAY THE SAME

THING, JOAN. I LOVE YOU. SO I HATE IT WHEN I CAN'T

SUPPORT WHAT YOU'RE SAYING, BUT I'M VERY COMFORTABLE

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WITH THIS MOTION. IF IT DOESN'T PASS, THEN I WOULD

SUGGEST THAT YOU PUT YOUR MOTION FORWARD.

MR. SHEEHY: I THINK SHERRY AND I ARE VERY

MUCH IN TUNE ON THIS. AND AGAIN, WE BOTH LOVE YOU,

JOAN.

MS. LANSING: WITH ALL OUR LOVE. I GUESS

WE RESPECT YOU SO MUCH, IT'S SO HARD FOR US TO

DISAGREE WITH YOU.

CHAIRMAN THOMAS: OKAY. JUST SO WE KNOW

WHAT THE MOTION IS AND THEN WE GO TO PUBLIC COMMENT,

THE MOVER AND SECONDER DO NOT ACCEPT THE FRIENDLY

AMENDMENT. SO THAT IS NOW OFF THE TABLE, MR.

HARRISON?

MR. HARRISON: THAT'S CORRECT.

CHAIRMAN THOMAS: OKAY. SO WE'RE BACK TO

THE ORIGINAL MOTION, WHICH IS TO MOVE APPROVAL OF

THE CONCEPT. MEMBERS OF THE PUBLIC.

DR. CHIU: ARLENE CHIU, CITY OF HOPE. I

WANT TO CONGRATULATE CIRM FOR SUCH A TIMELY AND

THOUGHTFUL INITIATIVE, WHICH BRINGS STEM CELL

RESEARCH TO A NEW LEVEL OF MATURITY.

I HAVE TWO QUICK QUESTIONS, BUT BEFORE I

ASK THEM, I'D LIKE TO JUST TAKE A MOMENT TO SAY HOW

SHOCKED AND DISMAYED I AM TO HEAR ABOUT DUANE ROTH'S

INJURIES. AND AS A FOUNDING MEMBER OF THIS

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COMMITTEE, HE HAS ALWAYS BEEN BALANCED, FAIR MINDED,

WITH A KEEN FOCUS ON THE ECONOMIC AND HEALTH

BENEFITS THAT STEM CELL RESEARCH BRINGS TO

CALIFORNIA AND TO THE WHOLE FIELD. SO I REMEMBER

HIM SAYING ONE TIME TO ME, "IN ACADEMIA YOU MEASURE

SUCCESS BY THE NUMBER OF PUBLICATIONS AND PATENTS

YOU HAVE, BUT THE PUBLIC MEASURES SUCCESS BY THE

NUMBER OF PATIENTS YOU'VE HELPED." AND I THINK THIS

INITIATIVE REALLY ADDRESSES THAT CONCERN. SO I WANT

TO JOIN ALL THE WISHERS IN THIS ROOM IN A SPEEDY AND

FULL RECOVERY FOR DUANE.

MS. LANSING: THANK YOU FOR SAYING THAT ON

BEHALF OF ALL OF US.

CHAIRMAN THOMAS: THANK YOU, ARLENE.

DR. CHIU: SO I HAVE TWO QUICK QUESTIONS

IN READING THE CONCEPT. AND I THINK IT MIGHT BE

JUST CONFUSION ON MY PART. BUT THE FIRST IS THAT IN

THE FIRST RFA WHICH ADDRESSES THE CLINICS, WILL

RESEARCH PATIENT'S TREATMENT AND COMPONENTS OF THE

TRIAL BE FUNDED BY A SEPARATE MECHANISM FOR CLINICAL

TRIALS? AM I CORRECT IN ASSUMING THAT IT'S NOT PART

OF THE $11 MILLION? THANK YOU.

MY SECOND QUESTION HAS TO DO WITH THE RFA

2 IN TERMS OF THE PI. MANY OF THE PI'S IN ACADEMIA

THAT FULFILL ALL THE REQUIREMENTS OF EXCELLENCE ARE

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ALREADY WORKING SOME PERCENTAGE OF THEIR TIME ON

COORDINATING CENTERS AND THEY HAVE THE EXPERIENCE

AND TRACK RECORD. IT SAYS IN THIS INITIATIVE THAT

YOU REQUIRE THE PI HAVE A HUNDRED PERCENT

COMMITMENT, AND THAT WOULD RULE OUT PEOPLE WHO

ALREADY ARE PARTIALLY COMMITTED FOR A FEW YEARS TO

OTHER COORDINATING CENTERS. SO I JUST WONDERED IF

IT WOULD BE POSSIBLE FOR A PI WHO COULD NOT FULFILL

A HUNDRED PERCENT RIGHT OFF THE BAT TO HIRE AN

ADMINISTRATOR OR A CLINICAL TRIALS OFFICER AT FULL

TIME TO HELP HIM OR HER UNTIL THEY MOVE INTO FORCE.

IT'S VERY HARD FOR A PI TO DIVEST THEMSELVES OF

OTHER ADMINISTRATIVE COMMITMENTS. SO THOSE ARE MY

TWO QUESTIONS. THANK YOU.

DR. MILLAN: I JUST WANTED TO ANSWER

ARLENE'S QUESTION. SO I DON'T THINK WE HAVE ANY

HARD AND FAST DECISION ON THAT RIGHT NOW. HOWEVER,

WE HAD SORT OF BUILT INTO OUR THINKING THAT THIS

WOULD RAMP UP, THIS ACTIVITY WOULD RAMP UP. SO IN

THE CONCEPT STATEMENT, WE SAID A HUNDRED PERCENT.

BUT I THINK WE MIGHT CONSIDER OTHER ALTERNATIVE

MODELS THAT ARE PUT FORWARD, AND THAT MAY BE

SOMETHING THAT WE THINK ABOUT AT THE RFA STAGE AND

HAVE A LITTLE CLEARER IDEA BECAUSE I DO UNDERSTAND

YOUR POINT. AND WE CERTAINLY WOULD WANT TO

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ENCOURAGE ACADEMIC ENTITIES TO APPLY FOR THIS AS

WELL AS FOR-PROFIT. SO I UNDERSTAND YOUR CONCERN

THERE.

MR. REED: HAVING WATCHED THE GERON TRIALS

GO THROUGH SEVEN YEARS OF AGONIZING SOMETIMES

INDECISION, IT SEEMED LIKE OFTENTIMES THE FDA DID

REALLY NOT KNOW WHAT TO DO NEXT. I SEE THIS AS A

WAY TO IMPOSE ORDER AND STRUCTURE ON CHAOS. I THINK

THIS IS SOMETHING THAT WILL CREATE A LASTING BENEFIT

FOR THE ENTIRE FIELD FOR EVERYONE. AND AS A PATIENT

ADVOCATE, I APPLAUD YOU. THANK YOU.

CHAIRMAN THOMAS: THANK YOU, DON. ANY

OTHER COMMENTS BY MEMBERS OF THE BOARD?

MS. SAMUELSON: ONE ADDITIONAL QUESTION.

WE HAVEN'T YET BEEN ABLE TO RECEIVE AN ASSESSMENT OF

OUR CURRENT GRANTS FUNDED PORTFOLIO. IF WE HAD

THAT, WE WOULD KNOW HOW SUCCESSFUL THE FUNDED GRANTS

HAVE BEEN MOVING THEM TOWARD CLINICAL TRIAL. AND SO

HOW BIG THAT CHALLENGE IS TO GET THERE AND WHETHER

WE CAN -- HOW MUCH TIME AND MONEY WE HAVE LEFT TO

FILL THAT REMAINING GAP BECAUSE THERE'S CERTAINLY A

GAP FOR LOTS OF DISEASES, AT LEAST PARKINSON'S. SO

I'M WONDERING IF A FRIENDLY AMENDMENT OF THAT SORT

WOULD BE APPROPRIATE.

CHAIRMAN THOMAS: I DON'T KNOW THAT THAT

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NEEDS TO BE AN AMENDMENT. I THINK DR. FEIGAL, JOAN,

KEEPS US POSTED ON PROGRESS OF ALL OF THE PROGRAMS

AS THEY HEAD TOWARDS CLINICAL TRIALS. IS THERE

SOMETHING BESIDES THAT THAT YOU'RE REFERRING TO?

MS. SAMUELSON: YEAH. YEAH. YEAH. YEAH.

SOMETHING THAT WOULD ASSESS THE STATUS OF THE FUNDED

GRANT. HOW FAR THE SCIENCE HAS MOVED ESSENTIALLY

OVER THE PORTFOLIO THAT HAS BEEN FUNDED. SOME

THINGS HAVEN'T MOVED FIVE INCHES, SOME HAVE TAKEN

BIG LEAPS. WHAT HAVE BEEN -- WHAT HAS BEEN THE

PROGRESS AND HOW MUCH DID IT COST US BECAUSE WE'RE

GOING TO HAVE TO MAKE JUDGMENTS ABOUT WHAT'S LEFT.

CHAIRMAN THOMAS: DR. FEIGAL.

DR. FEIGAL: I WILL DO MY BEST TO TRY AND

ANSWER YOUR CONCERNS. SO WHAT I DO RIGHT NOW IS AT

LEAST ON A YEARLY BASIS, AND I AM HAPPY TO DO IT

MORE FREQUENTLY, I COME TO THIS BOARD WITH AN UPDATE

ON PROGRESS ON ALL OF THE FUNDED DEVELOPMENT TEAMS.

AND I WOULD -- THE REASON WHY WE DO IT AT A POINT IN

TIME IS BECAUSE THEY GO THROUGH INTERVAL

INTERACTIONS WITH US AND WITH OUR ADVISORY PANEL.

AND JUST SO THAT WE'RE TREATING THEM AS A COHORT,

I'D LIKE TO HAVE A CERTAIN LEVEL OF EVALUATIONS TO

BE DONE BEFORE I BRING INFORMATION TO THIS BOARD SO

THAT IT'S COMPREHENSIVE AND COMPLETE.

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IF YOU'D LIKE ME TO DO IT ON A MORE

FREQUENT BASIS, WE CAN DO THAT. IF THERE'S

SOMETHING COMPELLING THAT WOULD BE PERTINENT FOR THE

BOARD TO KNOW, I CERTAINLY COULD RUN IT BY THE

CHAIRMAN AND SEE IF HE THINKS IT'S APPROPRIATE TO

BRING IT TO A FULLER AUDIENCE.

MS. SAMUELSON: IT'S NOT THE FREQUENCY.

IT'S THE DEPTH OF THE ANALYSIS. I RECEIVE THOSE.

I'M REAL INTERESTED IN THEM. I LOOK AT THEM ALL AND

THEY TALK ABOUT X DOLLARS GOING TO X DISEASE. IT'S

NOT SAYING THE SCIENCE WAS HERE AND NOW WE HAVE AN

ANIMAL MODEL OR A MORE SOPHISTICATED SENSE OF WHAT

THE THERAPEUTIC OPTIONS ARE AND SO ON. IT'S A MORE

ELABORATE AND INFORMATIVE TOOL.

CHAIRMAN THOMAS: OKAY. POINT WELL TAKEN,

JOAN. I THINK WE SHOULD -- WE CAN DISCUSS THIS OFF

LINE. I DON'T THINK THIS IS THE SUBJECT FOR AN

AMENDMENT BECAUSE THAT IS AN ONGOING CONCERN YOU'VE

HAD, WHICH IS A VERY VALID ONE, BUT NOT PARTICULARLY

PERTINENT, I THINK, TO THIS, BUT IT DOES REQUIRE

FURTHER DISCUSSION, WHICH I KNOW DR. FEIGAL WILL BE

HAPPY TO HAVE.

SO ARE THERE ANY OTHER COMMENTS BY MEMBERS

OF THE BOARD? OKAY. HEARING NONE, ROLL CALL,

PLEASE, MARIA.

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DR. BERGLUND: AYE.


DR. BRENNER: GREAT.


DR. DULIEGE: AYE.


MS. FEIT: AYE.


DR. FINE: AYE.


DR. FRIEDMAN: YES.


HAWGOOD.

DR. HAWGOOD: YES.


SHERRY LANSING.

MS. LANSING: YES.

MS. BONNEVILLE: BERT LUBIN. MICHAEL

MARLETTA. LLOYD MINOR.

DR. MINOR: YES.


DR. PRIETO: AYE.


DR. PULIAFITO: YES.

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DR. QUINT: YES.


MR. ROWLETT: YES.


MS. SAMUELSON: NO.


MR. SHEEHY: YES.


DR. STEWARD: YES.




MR. TORRES: AYE.


DR. VUORI: YES.


WINOKUR.

MS. WINOKUR: YES.

CHAIRMAN THOMAS: OKAY. MR. HARRISON, IS

IT SAFE TO SAY THE MOTION PASSES? THANK YOU. AND

AGAIN CONGRATULATIONS TO ALAN AND NATALIE AND MARIA

AND ALL STAFF WHO SPENT SO MANY HOURS, WEEKS, AND

MONTHS, NEIL TO YOUR MODELING, ALL OF OUR LEGAL

PEOPLE, ETC., ELLEN. I'M SURE I'LL LEAVE SOMEBODY

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OUT. ANYWAY, CONGRATULATIONS TO EVERYBODY. THIS IS

A BIG DEAL. SO THANK YOU.

WE'RE GOING TO SKIP DOWN TO ITEM NO. 13,

WHICH IS ONE OF THOSE MOMENTS THAT IS ALWAYS

BITTERSWEET BECAUSE IT IS THE CHANCE TO HONOR

SOMEBODY WHO'S HAD AN ENORMOUS CONTRIBUTION TO CIRM

OVER THE YEARS AND TO THE PATIENTS OF THE WORLD.

AND IT'S BITTERSWEET BECAUSE THEY'RE NO LONGER

MEMBERS OF THE BOARD. OTHERWISE WE WOULDN'T BE

HAVING THIS MOMENT.

IN THIS INSTANCE WE WANT TO HONOR ONE OF

OUR GIANTS OF THE PAST NUMBER OF YEARS WHOSE

CONTRIBUTION IS INCALCULABLE, DEAN PHIL PIZZO FROM

STANFORD. AND TO KICK OFF THE ROUND OF COMMENTS,

CALL UPON DR. FRIEDMAN.

DR. FRIEDMAN: IT'S MY PLEASURE TO BEGIN

THE PROPOSAL, THE CONSIDERATION OF THIS RESOLUTION

HONORING DR. PIZZO. I HAVE KNOWN PHIL FOR MORE THAN

THREE DECADES. PHIL IS ONE OF THE FEW PEOPLE IN THE

ROOM WHO REMEMBERS ME WITH HAIR, WHICH TELLS YOU HOW

LONG AGO IT'S BEEN.

THE COMMENTS I OFFER REALLY ARE ON BEHALF

OF THE CITIZENS OF THE STATE WHO HAVE BEEN VERY

FORTUNATE TO HAVE YOUR THOUGHTFUL ENGAGEMENT OVER A

REALLY EXTENDED PERIOD OF TIME. FROM THE VERY

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BEGINNING OF THE ORGANIZATION, FROM DECEMBER OF

2004, YOU'VE NOT ONLY BEEN SOMEONE WHO'S BEEN DEEPLY

ENGAGED IN THESE MEETINGS, WHICH ARE VERY IMPORTANT,

BUT SPENT AN ENORMOUS AMOUNT OF TIME OUTSIDE OF THIS

VENUE TRYING TO HELP WITH VARIOUS SUBCOMMITTEES AND

FORA.

WE'VE ALL HAD THE PLEASURE HERE WHO HAVE

SERVED WITH YOU OF YOUR THOUGHTFUL, SOBER, CAREFUL

COMMENTS, ADVICE, AND REALLY UNSELFISH HELP WITH THE

CONSIDERATIONS, ASKING THE QUESTION WHAT'S THE BEST

SCIENCE, BUT NOT SCIENCE IN AN ABSTRACT SENSE,

WHAT'S THE BEST SCIENCE THAT LEADS TO SOMETHING THAT

WILL HELP PEOPLE AND HOW TO DO SO IN THE SHORTEST

POSSIBLE PERIOD OF TIME.

WE'RE ALL VERY GRATEFUL FOR YOUR SERVICE

AND VERY APPRECIATIVE OF THE TREMENDOUS EFFORT THAT

YOU'VE OFFERED. AS HAS BEEN COMMENTED, WE ALL WILL

FEEL THE LOSS OF YOUR PRESENCE HERE, NOTWITHSTANDING

THE ABLE SERVICE OF NEW REPRESENTATION WHO I'M SURE

WILL DO A WONDERFUL JOB, BUT WE WILL MISS YOU VERY,

VERY MUCH. AND THANK YOU SO MUCH FOR EVERYTHING.

CHAIRMAN THOMAS: SHERRY.

MS. LANSING: YES. PHIL, I WISH I COULD

BE THERE TODAY BECAUSE THIS IS TRULY ONE OF THE MOST

BITTERSWEET DAYS SINCE THIS INSTITUTE WAS FORMED. I

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CAN STILL REMEMBER THE VERY FIRST MEETING AND YOU

WERE THERE. AND I WAS A VERY NERVOUS PATIENT

ADVOCATE FEELING RATHER INADEQUATE ABOUT MY

BACKGROUND. AND I THINK I SPEAK FOR ALL THE PATIENT

ADVOCATES IN SAYING THAT THERE WAS SOMETHING ABOUT

YOU THAT DREW US ALL TO YOU. THERE WAS A KINDNESS

IN YOUR FACE THAT CONTINUES TO THIS DAY AND A

WARMTH.

AND SO FOR ME PERSONALLY, AND ACTUALLY I

KNOW THAT ALL THE PATIENT ADVOCATES WHO WERE THERE

FROM THE BEGINNING WOULD SAY THE SAME THING, YOU

WERE A SOURCE FOR US THAT WE WOULD GO TO, WE WOULD

GO TO TO ASK MORE DETAILED QUESTIONS ABOUT THE

SCIENCE. AND YOU ALWAYS WERE SO PATIENT IN

EXPLAINING IT TO ME PERSONALLY, AND YOU NEVER MADE

ME FEEL SILLY OR STUPID FOR NOT UNDERSTANDING

SOMETHING. AND BY THE END OF IT, I DID UNDERSTAND

IT IN A PATIENT ADVOCATE WAY, NOT WITH ALL THE

DETAILS OF A SCIENTIST.

AND SO I WAS SO GRATEFUL FOR THE EXTRA

TIME THAT YOU GAVE ME FROM THE BEGINNING AND GAVE

ALL OF US WHO WERE PATIENT ADVOCATES AND CONTINUE TO

THIS DAY TO GIVE ME. BUT YOU WERE MUCH MORE THAN A

SOURCE OF SCIENTIFIC KNOWLEDGE FOR US. YOU ALSO

REPRESENTED THE ETHICS AND INTEGRITY OF THIS BOARD.

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YOU ARE UNCOMPROMISING AND YOU ALWAYS CARED ABOUT

WHAT WAS NOT ONLY BEST FOR THE SCIENCE, BEST FOR THE

PATIENTS, BUT ALSO EVERYTHING THAT WAS DONE IN FULL

TRANSPARENCY AND WITH FULL INTEGRITY AND FULL

ETHICS.

YOU KNOW, WHEN YOU SERVE ON A BOARD, THERE

WERE CERTAIN PEOPLE, BECAUSE OF THEIR VAST

KNOWLEDGE, BECAUSE OF THEIR ETHICS, BECAUSE OF THEIR

INTEGRITY, BECAUSE OF JUST WHO THEY ARE THAT WHEN

THEY SPEAK, EVERYBODY LISTENS. AND THAT'S WHO YOU

ARE, PHIL. YOU ARE THE PERSON THAT REALLY WAS ONE

OF THE CONSCIENCE OF THE INSTITUTE, ONE OF THE

GENIUSES OF THE INSTITUTE, AND SOMEONE WHO WHENEVER

YOU GAVE AN OPINION ALMOST ALWAYS YOU CARRIED THE

ROOM BECAUSE EVERYONE CARED WHAT YOU HAD TO SAY AND

LISTENED TO YOU.

I CAN'T IMAGINE CIRM WITHOUT YOU. I KNOW

WE WOULD NOT BE WHERE WE ARE TODAY WITHOUT YOU. SO

I EXPRESS A SPECIAL GRATITUDE ON BEHALF OF THE

CITIZENS, ON BEHALF OF THE PATIENT ADVOCATES, ON

BEHALF OF ANYONE WHO SUFFERS FROM ANY DISEASE FOR

EVERYTHING THAT YOU'VE DONE TO MAKE THIS INSTITUTE

SO SPECIAL. AND ON A PERSONAL LEVEL I THANK YOU FOR

YOUR FRIENDSHIP, AND I KNOW THAT OUR FRIENDSHIP WILL

CONTINUE FOREVER. SO THANK YOU, PHIL.

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CHAIRMAN THOMAS: DEAN HAWGOOD.

DR. HAWGOOD: PHIL, AS A FELLOW DEAN, I

JOINED THIS GROUP AFTER I KNOW MOST OF THE REALLY

HEAVY LIFTING HAD BEEN DONE, AND I REMEMBER MY FIRST

COUPLE OF MEETINGS NOTING YOUR INCREDIBLY ACTIVE

PARTICIPATION AND GETTING AN UNDERSTANDING OF JUST

HOW MUCH TIME AND EFFORT AND THOUGHT YOU HAD PUT

INTO THIS ORGANIZATION. AND KNOWING WHAT YOUR DAY

JOB WAS LIKE, I WAS JUST EVEN MORE IMPRESSED THAT

YOU HAD THAT ABILITY.

BUT MOST OF THE BOARD MEMBERS PROBABLY

KNOW, BUT DURING THE SAME TIME THAT PHIL WAS PUTTING

THE EFFORT INTO CIRM, HE WAS ALSO PLAYING OTHER

LEADERSHIP ROLES IN THE COUNTRY TO ADVANCE

PARTICULARLY THE RESEARCH MISSION THROUGH HIS WORK

ON THE AAMC, THE COUNCIL OF DEANS, AND MANY OTHER

ORGANIZATIONS. AND IT'S REALLY REMARKABLE THE

BANDWIDTH AND HIS ABILITY TO GET ALL OF THAT WORK

DONE AND NOT EVER LOOK FRUSTRATED OR HARRIED BY THE

TIME COMMITMENT THAT IT REQUIRED.

SO HE'S BEEN A REAL ROLE MODEL TO ME, AND

I SUSPECT I SPEAK ON BEHALF OF ALL OF THE DEANS ON

THE BOARD, THAT YOU'VE BEEN A GREAT COLLEAGUE AND

THANK YOU VERY MUCH. AND WE LOOK FORWARD TO WORKING

WITH YOUR SUCCESSOR NOW, AND I LOOK FORWARD TO MY

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RETIREMENT.

CHAIRMAN THOMAS: DON'T RETIRE ANY TIME

SOON, SAM. THANK YOU. SENATOR TORRES.

MR. TORRES: I KNOW PHILIP IN A DIFFERENT

WAY. MY SON WENT TO STANFORD AND HE MET A BEAUTIFUL

AFRICAN-AMERICAN ACTRESS AND PROFESSOR BY THE NAME

OF ANNA DEAVERE SMITH, WHO SINCE THEN AND STILL IS

HIS MENTOR. AND SHE CREATED A ONE-WOMAN SHOW ON

BROADWAY WHERE SHE TALKED ABOUT THE HEALTHCARE

CRISIS IN AMERICA, AND THE PLAY WAS CALLED LET ME

DOWN EASY.

YOU MAY REMEMBER ANNA DEAVERE SMITH FROM

NURSE JACKIE AND OTHER KINDS OF SHOWS THAT SHE'S

DONE. BUT IN THIS PLAY SHE PORTRAYED A VERY DEAR

FRIEND OF MINE WHO HAD SINCE PASSED, FORMER GOVERNOR

OF TEXAS, ANN RICHARDS, LANCE ARMSTRONG, THE MODEL

LOREN HUTTON, AND JOEL SIEGEL, THE FILM CRITIC, AND

DR. PHIL PIZZO.

SO WHEN ANNA WALKED ON THE STAGE IN A

MEDICAL WHITE UNIFORM AND I SAW PHIL PIZZO'S NAME

TAG, AND I SAID, "JOAQUIN," I SAID TO MY SON BECAUSE

HE WAS AT THE PLAY, "WHY IS PHIL PIZZO IN THE PLAY?"

AND HE EXPLAINED TO ME THAT YOU AND ANNA DEAVERE

SMITH HAD BEEN VERY DEAR FRIENDS. AND THE WORK THAT

YOU'VE DONE OVER THE DECADES, ESPECIALLY WITH

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CHILDREN, HAS NOT ONLY BEEN RECOGNIZED BY THIS

INSTITUTE AND BOARD, BUT BY MANY OTHER ORGANIZATIONS

ACROSS THE COUNTRY.

AND I APPLAUD YOU FOR THOSE AWARDS. BUT I

ALSO APPLAUD YOU FOR HAVING THE COURAGE AND THE

SENSIBILITY AND PATIENCE WHEN PATIENTS WITH

INCURABLE DISEASES OR THEIR FAMILIES WOULD COME TO

OUR BOARD AND CONFRONT US WITH A DECISION THAT WAS

VERY DIFFICULT. AND I RESPECT AND ADMIRED YOUR

COUNSEL DURING THOSE VERY DIFFICULT TIMES AND

FOLLOWED IT OFTEN.

SO I JUST WANT TO SAY NOT ONLY WILL I MISS

YOU ON THIS BOARD, BECAUSE I WON'T SEE YOU AS OFTEN,

I'LL TRY AND GET DOWN THERE AS OFTEN AS I CAN, BUT I

WANTED THIS BOARD TO KNOW THAT YOU ARE NOT ONLY A

NATIONAL FIGURE IN HEALTH, BUT IN THE ARTS AS WELL,

AND THAT YOU PROBABLY COULD STAR IN YOUR OWN PLAY AT

SOME TIME IN THE FUTURE. SO I LOVE YOU, PHIL.

CHAIRMAN THOMAS: OTHER COMMENTS BY

MEMBERS OF THE BOARD? DR. TROUNSON.

DR. TROUNSON: WELL, I CAN'T TURN ROUND

AND DO THIS, PHIL, BUT IT'S REALLY BEEN AN HONOR TO

KNOW YOU AND INTERACT WITH YOU. AND REALLY AN

INTELLECT LIKE YOURS DOESN'T COME OFTEN AROUND, AND

TO BE ABLE TO DEAL WITH THOSE SCIENTISTS THAT I KNOW

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SO VERY WELL AND YOU DO, NOT ONLY AT STANFORD, BUT

AROUND CALIFORNIA AND THROUGH THE U.S., THEY ALL

ADMIRE YOU MUCH. AND YOU'RE JUST A FANTASTIC MAN,

AND I'VE APPRECIATED ALL THE WISE COUNSEL THAT I'VE

NEEDED FROM TIME TO TIME WHICH YOU ALWAYS GAVE, AND

I THINK THIS HAS MADE THIS A MORE INTERACTIVE AND A

BETTER PLACE TO BE, AND IT CERTAINLY HELPED ME TO

STAY AS LONG AS I HAVE ALREADY.

SO I REALLY WISH YOU THE BEST, AND I HOPE,

LIKE EVERYBODY ELSE, THAT WE CAN SPEND A BIT OF TIME

SOME OTHER TIME GOING FORWARD. ALL THE BEST, PHIL,

AND THANK YOU VERY MUCH FOR ALL YOU'VE DONE FOR US

AND ALL THE STAFF AT CIRM AND ALL THE SCIENTISTS OF

CALIFORNIA AND BEYOND. WE REALLY DO APPRECIATE IT.

CHAIRMAN THOMAS: PHIL, IF YOU COULD JUST

COME UP HERE WHILE I'M MAKING A COUPLE STATEMENTS.

YOU COULD COME UP RIGHT NOW. THAT WOULD BE GREAT.

I'D LIKE TO ECHO WHAT EVERYBODY SAID. I KNOW WHEN I

STARTED -- FIRST OF ALL, AS A PERSONAL NOTE, PHIL, I

WANTED TO THANK YOU VERY MUCH FOR PHONING IN FROM

ISTANBUL WHEN THE VOTE WAS TAKEN FOR THE NEW CHAIR

POSITION, WHICH I PERSONALLY GREATLY APPRECIATED.

SO THANK YOU AGAIN FOR THAT.

I THINK SHERRY, ALL THE COMMENTS THAT SHE

MADE, ONE THAT STICKS OUT, AND BEING A FINANCIAL

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GUY, HARKENS BACK TO THE DAYS OF E. F. HUTTON. FOR

THOSE OF YOU WHO REMEMBER, MANY ITERATIONS OF

INVESTMENT BANKS AGO AND THE COMMENT, THE ADS THAT

HE HAD WAS WHEN E. F. HUTTON TALKS, PEOPLE LISTEN.

AND I SORT OF THINK OF PHIL AS THE E. F. HUTTON OF

THE BOARD.

THERE WAS A GRAVITY TO ALL YOU SAID, A

WISDOM, A SENSE OF FAIRNESS AND DEDICATION TO

ANALYZING ALL SIDES OF THE ISSUE THAT LED YOU TO

FORMULATE YOUR OPINION, WHICH WAS SOMETHING TAKEN

VERY SERIOUSLY. AND PEOPLE ON THE BOARD WOULD

LITERALLY SIT ON THE EDGE OF THEIR SEATS TO SEE WHAT

PHIL PIZZO HAD TO SAY ON THE SUBJECT. AND AS SHERRY

SAID, MOST OFTEN THAT OPINION CARRIED THE DAY. SUCH

WAS THE RESPECT PEOPLE AFFORDED YOU AND THE GRAVITY

OF WHAT YOU SAID AND THE WISDOM.

SO I WOULD LIKE TO JOIN ALL MY FELLOW

BOARD MEMBERS IN CONGRATULATING YOU ON THE

TREMENDOUS CONTRIBUTION TO CIRM, TO THE MEDICAL

FIELD IN CALIFORNIA, AND TO THE NATION AND BEYOND.

AND ON BEHALF OF CIRM WANT TO PRESENT YOU THIS

FRAMED RESOLUTION, WHICH WILL BE SOMETHING TO ADD TO

YOUR DECOROUS WALLS IN YOUR OFFICE IF YOU EVEN HAVE

SPACE BECAUSE YOU'VE RECEIVED SO MANY HONORS TO

DATE. SO ON BEHALF OF CIRM, PHIL -- AND BY THE WAY,

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I DO HOPE YOU WILL HAVE A COMMENT OR TWO -- WANT TO

CONGRATULATE YOU AND GIVE YOU THIS HEARTFELT

RESOLUTION FOR ALL YOUR WONDERFUL HELP.

(APPLAUSE.)

DR. PIZZO: I WANT TO BEGIN BY, OF COURSE,

THANKING ALL OF YOU. I'M DEEPLY HUMBLED TO BE HERE.

AND I FEEL LIKE I'M ALMOST AT THE POINT OF LISTENING

TO AN OBITUARY, NONETHELESS VERY, VERY MEANINGFUL.

AND I WOULD SAY, QUITE HONESTLY, THAT REALLY THE

HONOR HAS BEEN MINE TO SERVE WITH YOU. OVER THE

YEARS THAT WE'VE WORKED TOGETHER AS AN ICOC, STAFF

REALLY COLLABORATING WITH US TOGETHER, THE WONDERFUL

GROUP THAT'S BEEN ASSEMBLED, AND THOSE OF US WHO

HAVE BEEN HERE FROM THE BEGINNING REMEMBERING HOW

HARD IT WAS TO GET THIS PROCESS GOING. AND TO

WITNESS WHAT'S BEEN ACCOMPLISHED OVER THE LAST EIGHT

YEARS IS TRULY EXTRAORDINARY.

MOST OF US NEVER ASSUMED IN OUR LIVES THAT

WE WOULD HAVE BEEN HERE. THIS WAS NOT ON THE PATH

OF THE JOURNEY THAT WE THOUGHT WE WOULD TAKE. AND

WHEN THE VISION -- YOU KNOW, BOB KLEIN AND MANY

OTHERS REALLY BROUGHT PROP 71 TO FRUITION IN 2004.

FIRST OF ALL, THAT WAS A MOMENT AS A NEW CALIFORNIAN

THAT I SAID I'M REALLY PROUD TO BE A CALIFORNIAN.

THIS IS A STATE THAT HAS A VISION FOR THE FUTURE AND

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RECOGNIZED THAT STEM CELL BIOLOGY AND REGENERATIVE

MEDICINE WAS IMPORTANT AND REALLY GAVE LIFE TO THIS

ORGANIZATION. AND WHAT EACH OF YOU IN THIS ROOM DID

AND THE MANY WHO SERVED ALONG THE WAY HAS TAKEN THAT

SEED OF LIFE AND REALLY ALLOWED IT TO HAVE THE SET

OF ACHIEVEMENTS THAT ARE NONPARALLELED.

LOOK AROUND AT WHAT'S HAPPENED, NEW

INVESTIGATORS, NEW ACCOMPLISHMENTS AND RESEARCH THAT

WOULDN'T HAVE HAPPENED. WITHOUT CIRM I CAN'T EVEN

IMAGINE THAT IPS WOULD HAVE EXISTED IN THE WAY THAT

IT HAS TODAY. LOOK AT WHAT'S HAPPENED IN TERMS OF

OUR STATE AND THE INFRASTRUCTURE THAT'S BEEN

DEVELOPED IN TERMS OF A COMMITMENT TO THIS RESEARCH.

AND INDEED EVERY DAY AS I GO INTO MY NEW OFFICE IN

THE LORRY LOKEY STEM CELL RESEARCH BUILDING, I'M

REMINDED EVEN MORE FIGURATIVELY ABOUT HOW IMPORTANT

THIS IS.

MY HOPE, OF COURSE, LIKE YOURS, IS THAT

THE INCREDIBLE INVESTMENT THAT'S BEEN MADE IN THIS

EFFORT TO DATE ALONG WITH THE PROGRESS ACHIEVED WILL

BE MET BY REGENERATION OF CIRM OVER TIME SO THAT

THIS WORK CAN CONTINUE AND REALLY BRING TO THOSE

CITIZENS OF CALIFORNIA WHO SAW AND ENVISIONED A NEED

AND A BENEFIT THE TRUE FRUITION AND ACCOMPLISHMENTS

BY DISCOVERIES AND INNOVATIONS THAT ARE COMING FROM

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THE LABORATORY TO PATIENTS, NOT ONLY HERE, BUT, OF

COURSE, AROUND THE WORLD.

SO AS I CLOSE, I WANT TO THANK YOU FOR

TEACHING ME, FOR YOUR COLLEGIALITY, FOR YOUR

FRIENDSHIP, FOR THE PARTICIPATION THAT WE'VE HAD

TOGETHER. THIS HAS BECOME ITS ONLY FAMILY UNIT IN

MANY WAYS. WE'VE HAD OUR OPPORTUNITIES TO KNOW EACH

OTHER AND LEARN ABOUT EACH OTHER AND TO REALLY CARE

ABOUT THE MISSION THAT CIRM IS ABOUT. AND I WISH

YOU ALL THE VERY BEST IN THE FUTURE. AND WHATEVER I

CAN DO ON THE SIDELINES TO HELP WITH THE

CONTINUATION OF FUNDING, YOU CAN COUNT ON THAT. I

REALIZE THIS IS RECORDED, BUT YOU CAN COUNT ON ME

BEING SOMEONE WHO WILL STAND FOR THE CONTINUATION OF

CIRM BECAUSE IT'S GOOD FOR THE WORLD. AND THAT'S

WHAT YOU'RE ABOUT. THANK YOU AGAIN.

(APPLAUSE.)

CHAIRMAN THOMAS: OKAY. I THINK THIS IS A

GOOD TIME TO GO GRAB OUR LUNCH ACROSS THE HALL. AND

PLEASE, AFTER YOU'VE TAKEN A RESTROOM BREAK AS WELL,

BRING YOUR LUNCH BACK HERE. WE'RE GOING TO CONTINUE

WITH THE AGENDA THROUGH A WORKING LUNCH. THANK YOU.

(A RECESS WAS TAKEN.)

CHAIRMAN THOMAS: OKAY. WE ARE NOW

RESUMING THE ICOC MEETING POST EVERYBODY GETTING

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THEIR LUNCH. PROCEED TO ITEM NO. 8, CONSIDERATION

OF THE CONCEPT PROPOSAL FOR TOOLS AND TECHNOLOGIES

III. LILA.

DR. COLLINS: GOOD AFTERNOON, MR.

CHAIRMAN, MEMBERS OF THE BOARD, AND AUDIENCE. TODAY

I'D LIKE TO MOVE BACK INTO THE TRANSLATIONAL SPACE

AND PRESENT TO YOU THE CONCEPT PROPOSAL FOR THE

THIRD CALL OF OUR TOOLS AND TECHNOLOGIES INITIATIVE.

THIS IS AGENDA ITEM NO. 8 IN YOUR BINDERS, AND YOU

SHOULD ALSO HAVE THE CONCEPT PROPOSAL THERE.

BEFORE I BEGIN, I'D LIKE TO JUST GIVE A

LITTLE REFRESHER ON THE PURPOSE OF THE TOOLS

INITIATIVE AS WE HAVEN'T DISCUSSED IT IN SOME TIME.

AND I THINK IT'S INTENDED TO ADDRESS SOME OF THE

ISSUES THAT JOAN RAISED AND JEFF ALLUDED TO EARLIER.

NOW, THE GOAL IS QUITE BROADLY TO ENABLE

TRANSLATIONAL STEM CELL RESEARCH BY ADDRESSING SOME

OF THE CHALLENGES SPECIFIC TO OUR FIELD. AND THIS

INITIATIVE IS REALLY FAIRLY UNIQUE TO CIRM, AND IT'S

REALLY EAGERLY ANTICIPATED BY OUR APPLICANTS AND

GRANTEES IN THAT IT DOES SOMETHING THAT A LOT OF

AGENCIES DON'T DO. WE FUND DEVELOPMENT NOT ONLY OF

TECHNOLOGIES, BUT ALSO OF DEVICES THROUGH THIS

INITIATIVE. AND IT FOSTERS MULTIDISCIPLINARY

COLLABORATIONS, AND A FAIR NUMBER OF INVENTIONS COME

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OUT OF THIS TYPE OF WORK AS WELL.

IT'S BEEN A PRODUCTIVE PROGRAM SO FAR.

YOU WILL RECALL DR. OLSON PRESENTED YOU SOME

OUTCOMES OF THE TOOLS AND TECHNOLOGIES I RFA IN

JANUARY. AND THE TOOLS AND TECHNOLOGIES II RFA IS

STILL IN PROCESS, OR THOSE AWARDS ARE STILL ONGOING,

AND WE SHOULD HAVE OUTCOMES OF THAT RFA. I BELIEVE

IN 2014 THOSE SHOULD BE COMPLETED. SO NEXT YEAR

WE'LL HEAR ABOUT THOSE.

SO I'D LIKE TO JUST SPEND A FEW MOMENTS

AND DISCUSS SOME OF THE CHALLENGES THAT WE DO FACE

IN THE TRANSLATION OF STEM CELL THERAPIES BECAUSE

THERE ARE SOME SPECIAL CHALLENGES IN THE FIELD. SO

LISTED IN THIS SLIDE ARE SOME OF THE THINGS THAT

WE'D LIKE STEM CELLS TO DO. AND UNDERNEATH THOSE

THINGS ARE WHAT WE NEED TO ACHIEVE TO ACCOMPLISH THE

GOALS.

NOW, THE FIRST POINT HERE REALLY GETS TO

THE CORE GOAL OF REGENERATIVE MEDICINE. AND IN A

NUMBER OF DISEASES AND INJURIES, IT JUST MAY NOT BE

POSSIBLE TO INDUCE THE BODY TO HEAL ITSELF. SO IN

THESE CASES, IN ORDER TO REPLACE DAMAGED TISSUES, WE

NEED THE CELLS THAT WE DELIVER TO PERSIST AND

FUNCTION IN THE PATIENT. AND THE CHALLENGE WE FACE

HERE IS MULTIFACETED. FIRST, A NUMBER OF THE CELLS

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THAT WE TRANSPLANT ARE LOST SHORTLY AFTER DELIVERY.

WE NEED BETTER METHODS TO DELIVER CELLS. WE ALSO

NEED THE CELLS TO INTEGRATE INTO A TISSUE IN A

FUNCTIONAL WAY.

AND I'LL GIVE AN EXAMPLE OF A

CARDIOMYOCYTE. IN ORDER FOR THAT CELL TO SUPPORT

THE PUMPING FUNCTION OF THE HEART, IT NEEDS TO GET

TO WHERE IT'S NEEDED AND NEEDS TO STAY THERE AND

NEEDS TO SURVIVE, IT NEEDS TO COMMUNICATE WITH THE

CELLS OF THAT HOST HEART FOR IT TO REALLY HELP. SO

WE NEED TO FIND WAYS TO BE ABLE TO HAVE CELLS

ACHIEVE THAT LASTING FUNCTIONAL ENGRAFTMENT.

TO THE NEXT POINT, ANIMAL MODELING, REALLY

THE PURPOSE OF USING ANIMAL MODELS IN TRANSLATION IS

TO BETTER PREDICT WHAT WILL HAPPEN IN THE CLINIC AND

TO BETTER DESIGN CLINICAL TRIALS. AND IT'S CLEAR

FOR SOME INDICATIONS THAT THE ANIMAL MODELS THAT WE

HAVE ARE JUST NOT ADEQUATE. PARTICULARLY THERE CAN

BE AN ISSUE USING SMALL ANIMAL MODELS TO TRY TO

PREDICT WHAT WOULD HAPPEN IN HUMANS. SO, FOR

EXAMPLE, IF YOU HAVE A NEURON THAT NEEDS TO PROJECT

TO A DISTANT SITE IN THE BRAIN, THE ABILITIES OF

THAT NEURON TO PROJECT IN THE TINY BRAIN OF A MOUSE

MAY NOT PREDICT WHAT THAT NEURON CAN DO IN A MUCH

LARGER HUMAN BRAIN. IN THE CASE OF OUR

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CARDIOMYOCYTE, IN ORDER FOR THAT CELL TO CONTRIBUTE

PUMPING FUNCTION, IT NEEDS TO BE PLACED IN A HOST

THAT HAS A HEART RATE THAT'S PHYSIOLOGICALLY

RELEVANT TO HUMANS.

SO THE CHALLENGE TO DOING THIS KIND OF

WORK IS THAT THE VAST MAJORITY OF THE LARGE ANIMAL

MODELS THAT WE HAVE ARE ACTUALLY IMMUNE COMPETENT.

AND AS A RESULT OF THAT, THEY TEND TO REJECT OUR

CELLS. AND DESPITE QUITE A BIT OF EFFORT, IT HAS

BEEN QUITE DIFFICULT TO ACHIEVE IMMUNOSUPPRESSION

REGIMENS THAT WILL ALLOW FOR A PROLONGED RETENTION

OF THE HUMAN XENOGRAPHS IN THESE MODELS. SO THIS IS

AN AREA WHERE WE CAN HAVE SOME IMPROVEMENT.

FINALLY, ONE OF THE GREATEST STRENGTHS OF

THE CELL THERAPY, THE ABILITY OF CELLS TO PERSIST

AND EVEN PROLIFERATE IN VIVO, CAN ALSO RAISE SAFETY

CONCERNS. AND IN ORDER TO REALLY EVALUATE THAT, WE

NEED TO BE ABLE TO TRACK OURSELVES OVER TIME IN VIVO

AND WE NEED THE TOOLS TO DO THAT.

AND THE LAST POINT GOES TO SOME OF THE

REAGENTS AND THE NEED TO DEVELOP COST-EFFICIENT STEM

CELL PRODUCTION PROCESSES. AND WE REALLY STILL HAVE

A NEED TO REPLACE SOME OF THE ANIMAL-DERIVED

PRODUCTS OR ANIMAL-DERIVED REAGENTS THAT WE USE IN

THESE PROCESSES THAT CAN BE INCONSISTENT, THAT CAN

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CAUSE EXPENSIVE LOTS FAILURES, AND IN ADDITION THEY

CAN IMPOSE A BURDEN OF EXTRA INFECTIOUS AGENT

TESTING ON THOSE PROGRAMS.

NOW, GETTING TO THE RFA, I THINK THIS IS

REALLY OUR OPPORTUNITY TO IMPACT THESE PROBLEMS AND

REALLY HELP MOVE THE FIELD FORWARD AND ADDRESS SOME

OF THE CONCERNS THAT YOU RAISED IN OUR EARLIER

DISCUSSION, JOAN. WE REALLY WANT TO ENABLE

TRANSLATION OF STEM CELL THERAPIES BY SUPPORTING THE

TYPES OF PROJECTS THAT ADDRESS THESE TRANSLATIONAL

BOTTLENECKS THAT ARE BROADLY APPLICABLE AND CAN BE

USED BY MULTIPLE PROGRAMS IN THE FIELD. SO THIS

COULD INCLUDE CREATION AND TESTING OF NEW TOOLS AND

TECHNOLOGIES OR ALSO OPTIMIZATION OF AN APPLICATION

OF EXISTING TOOLS AND TECHNOLOGIES TO OUR FIELD.

LISTED BELOW ARE SOME OF THE BOTTLENECKS

THAT WE'VE IDENTIFIED TO BE ESPECIALLY IMPORTANT TO

ADDRESS IN THIS RFA. I MENTIONED THE NEED FOR CELLS

TO REALLY ENGRAFT, SURVIVE, INTEGRATE TO SUPPORT

FUNCTION. WE ANTICIPATE THIS COULD BE ACCOMPLISHED

BY TISSUE ENGINEERING APPROACHES, BY SOME OF THE

NANOTECHNOLOGY APPROACHES THAT WERE ALLUDED TO THIS

MORNING TO ENABLE CELLS TO GO WHERE THEY NEED TO GO.

THE SECOND POINT IS TO REALLY TRY TO

IMPROVE THE INFORMATION THAT WE'RE ABLE TO GET OUT

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OF LARGE ANIMAL MODELS. SO WE WOULD LIKE TO SEE

PROGRAMS THAT WOULD HELP US ESTABLISH LONG-TERM

HUMAN CELL ENGRAFTMENT EITHER THROUGH THE

DEVELOPMENT OF NOVEL STRAINS OF ANIMALS THAT MIGHT

BE IMMUNE DEFICIENT AND WILLING TO ACCEPT HUMAN

GRAFTS OR THROUGH IMMUNOSUPPRESSION REGIMENS,

EFFORTS TO INDUCE GRAPH TOLERANCE. THOSE TYPES OF

PROGRAMS COULD REALLY BE HELPFUL.

AND THE SECOND POINT HAS ACTUALLY RECEIVED

A LOT OF ENTHUSIASM, AND THAT'S THE CONCEPT OF

REALLY DEVELOPING SURROGATE DEVELOPMENT CANDIDATE

CELLS THAT COULD BE USED TO ENABLE SAME SPECIES

MODELING IN THOSE LARGE ANIMALS SO THAT WE COULD

REALLY GET AN IDEA IN AN IMMUNE COMPETENT SYSTEM

ABOUT THE MECHANISM OF ACTION OF OUR CANDIDATES

WITHOUT HAVING TO WORRY ABOUT THAT IMMUNE REJECTION

COMPONENT.

SO THOSE ARE SORT OF TWO SIDES OF THE SAME

COIN, TO TRY TO GET SOME TOOLS TO GET A BETTER

UNDERSTANDING IN THOSE TYPES OF MODELS.

FINALLY, I NOTED THE IMPORTANCE OF BEING

ABLE TO TRACK CELLS AT HIGH SENSITIVITY. WE HAVE

CONCERNS OF OFF-TARGET TISSUE FORMATION THAT WE WANT

TO BE ABLE TO MONITOR. AND PREFERABLY WE'LL HAVE

TOOLS TO MONITOR OVER LONG PERIODS OF TIME.

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I ALLUDED TO THE NEED FOR XENOBIOTIC FREE

REAGENTS. THOSE WOULD BE THINGS LIKE EXTRACELLULAR

MATRICES THAT WE USE TO SUPPORT PLURIPOTENT STEM

CELL GROWTH, GROWTH FACTORS, THOSE TYPES OF THINGS.

THIS NEXT POINT IS A KNOWN BOTTLENECK IN

THE FIELD, AND THAT IS THE GENERATION OF TRUE

RECONSTITUTING HEMATOPOIETIC STEM CELLS. I THINK

THAT THIS IS NOT JUST A BOTTLENECK. IT'S ALSO A

TREMENDOUS OPPORTUNITY FOR CIRM. IF WE COULD BREAK

THROUGH THIS, IMAGINE, CALIFORNIA IS ON THE VERGE OF

BECOMING A MAJORITY/MINORITY STATE. AND IT'S VERY

DIFFICULT FOR A LOT OF PEOPLE TO FIND A MATCH TO A

HEMATOPOIETIC STEM CELL DONOR. IF WE COULD CRACK

THAT NUT AND GET HEMATOPOIETIC STEM CELLS, MATCHED

TRANSPLANTS FOR EVERYONE WHO NEEDS THEM, YOU IMAGINE

WHAT WE COULD DO. SO WE THINK THIS IS AN ENORMOUS

OPPORTUNITY FOR US.

AND NANOTECHNOLOGIES, I REALLY CONSIDER

THIS COULD BE A VERY POWERFUL TOOL FOR US TO HELP

CONTROL CELL DELIVERY TO TARGETED SITES, TO HELP

CONTROL CELL BEHAVIOR IN VIVO, AND POTENTIALLY EVEN

MONITOR BY DISTRIBUTION OF CELLS, AND WE COULD EVEN

HAVE SUICIDE SWITCHES TO ELIMINATE ROGUE CELLS IN

VIVO.

MOVING TO THE SPECIFICS OF THE AWARDS,

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WE'RE ASKING FOR A 20-PERCENT MINIMUM PERCENT EFFORT

COMMITMENT FROM OUR INVESTIGATORS. AND THE RFA IS

OPEN TO OUR COLLABORATIVE FUNDING PROGRAM. AND IT'S

ALSO OPEN TO ACADEMIC NOT-FOR-PROFIT AND FOR-PROFIT

INSTITUTIONS. WE'RE ASKING YOU FOR A TOTAL BUDGET

OF $35 MILLION TO SUPPORT THIS PROGRAM, AND WE'RE

ANTICIPATING APPROXIMATELY 20 AWARDS OF THREE YEARS

APIECE WITH UP TO $900,000 IN DIRECT PROJECT COST

EACH. AND WE'RE ALSO ASKING FOR A SUPPLEMENT IN THE

CASE OF LARGE ANIMAL MODELING. WE REALIZE THAT THIS

IS A COSTLY EFFORT, AND FOR THESE AWARDS WE'D

CONSIDER UP TO $1.2 MILLION OF JUSTIFIABLE TOTAL

DIRECT PROJECT COST FOR THAT EFFORT.

SO WE'D LIKE TO PRODUCE THE RFA BY

SEPTEMBER AND COME BACK TO YOU AGAIN NEXT SEPTEMBER

WITH THE RESULTS OF THE GRANTS WORKING GROUP REVIEW

THAT WILL HAPPEN NEXT SUMMER. AND THAT CONCLUDES

THE PROPOSAL, AND AT THIS TIME I'D LIKE TO REQUEST

YOUR APPROVAL OF THE CONCEPT PLAN FOR THE TOOLS AND

TECHNOLOGIES III RFA.

CHAIRMAN THOMAS: ARE THERE QUESTIONS?

YES, MR. SHEEHY.

MR. SHEEHY: ON DEVELOPMENT AND TESTING OF

CLINICALLY COMPATIBLE TECHNOLOGIES WITHIN THAT

BUCKET, WOULD THAT INCLUDE EFFORTS TO FACILITATE OR

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INDUCE IMMUNE TOLERANCE? BECAUSE IT SEEMS LIKE --

YOU'RE PROBABLY GOING TO GET A BUNCH OF

IMMUNOLOGISTS IN THE REVIEW FOR HEMATOPOIETIC STEM

CELLS. IMMUNE TOLERANCE IS A BIG BARRIER. WILL

THERE BE -- WOULD THOSE BE IN SCOPE?

DR. COLLINS: I THINK A TECHNOLOGY TO

IMPROVE FUNCTION OF A STEM CELL THERAPY SHOULD

ABSOLUTELY BE IN SCOPE. IMMUNOLOGY IS A BIG PIECE,

YES.

MR. SHEEHY: I THINK YOU'RE PROBABLY GOING

TO HAVE A LITTLE BIT HEAVIER IMMUNOLOGIC -- BECAUSE

IF YOU LOOK AT THE HSC THING, YOU MIGHT CONSIDER

MAYBE EMPHASIZING THAT A LITTLE BIT MORE WHEN YOU

ACTUALLY DO THE RFA. THERE'S SOME INTERESTING STUFF

OUT THERE, I THINK.

DR. TROUNSON: THE REASON IT'S INTERESTING

OUT THERE, AND I THINK WE HAD THAT IMMUNE RFA, AND

IT'S KIND OF ALMOST TIME TO CATCH UP WITH THAT AND

JUST SEE IS THERE A NEXT STEP. THERE ARE SEVERAL

REALLY GOOD PAPERS, AND THERE'S A WHOLE T-CELL

TECHNOLOGY WHICH HAS REALLY MOVED ALONG

DRAMATICALLY. SO I THINK WE OUGHT TO BE RECEPTIVE

TO THOSE THINGS, TO BE HONEST. AND SO MAKING SURE

WE'VE GOT THE APPROPRIATE TEAM TO REVIEW IS GOING TO

BE CRITICAL.

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MR. SHEEHY: WHEN YOU DO THE RFA, YOU

MIGHT WANT TO ASK BECAUSE YOU'RE GOING TO HAVE THOSE

PEOPLE ANYWAY FOR THE HSC PART.

CHAIRMAN THOMAS: OTHER QUESTIONS OF DR.

COLLINS? DEAN PULIAFITO.

DR. PULIAFITO: I MOVE THAT WE APPROVE

THIS CONCEPT EXTENSION.

CHAIRMAN THOMAS: IS THERE A SECOND?

MR. SHEEHY: SECOND.

CHAIRMAN THOMAS: MOVED BY DEAN PULIAFITO,

SECONDED BY MR. SHEEHY. ADDITIONAL --

LILA, I'M SORRY. I DIDN'T MEAN TO

INTERRUPT YOU THERE. YOU DIDN'T WANT TO BE

INTERRUPTING THAT FOR SURE. OTHER QUESTIONS,

COMMENTS FROM MEMBERS OF THE BOARD?

MS. SAMUELSON: I HAVE A QUESTION.

CHAIRMAN THOMAS: YES, JOAN.

MS. SAMUELSON: WHERE IN THIS VALUATION

THAT WE'RE DOING, AND LEADING UP TO A VOTE, WHERE

DOES IT FIT IN THE QUESTION OF HOW IMPORTANT ARE

THESE GRANT OBJECTIVES OF THE APPLICANTS WHO WILL

APPLY RELATIVE TO APPLICANTS WHO ARE TRYING TO GET

AN EARLY TRANSLATION GRANT FUNDED SO THAT THEY CAN

GET INTO THE GATE AND KEEP HAVING PROBLEMS BECAUSE

THEIR SCIENTIFIC PROBLEMS ARE GNARLY. A LOT OF THE

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NEURODEGENERATIVE DISORDERS AND MOST OF THE OTHERS

THAT WE SEE NOT QUITE MAKE THE GRADE BECAUSE IT'S

RISKY AND THAT IS PERCEIVED AS NOT ENOUGH DATA, ETC.

BUT THOSE ARE OBVIOUSLY EXTREMELY IMPORTANT BECAUSE

THE THING YOU WANT MOST IS JUST TO GET SOME SORT OF

EFFECTIVE THERAPY, AND YOU GOT TO GO THROUGH THAT

WICKET.

DR. COLLINS: SO I WOULD SAY, JOAN, THAT

MAYBE SOME OF THE REASON THAT SOME OF OUR

THERAPEUTIC AREAS ARE HAVING A DIFFICULT TIME MOVING

FORWARD IN THE PIPELINE IS OWING TO THESE

BOTTLENECKS. SO WE THINK THAT IF WE WERE ABLE TO

RESOLVE SOME OF THOSE, THEN THOSE FIELDS WILL REALLY

BE SPARKED TO MOVE FORWARD FASTER.

MS. SAMUELSON: HOW DO YOU TEST THAT OUT?

IS THERE ANY WAY TO DO IT TO KNOW?

DR. COLLINS: WE'D HOPE THAT, AND THIS

WILL BE IN THE RFA, THAT WHEN PEOPLE ARE DEVELOPING

THESE TOOLS AND TECHNOLOGIES, THAT THEY'RE GOING TO

BE WORKING TOGETHER WITH STEM CELL SCIENTISTS TO

BETA TEST THEM IN THE CONTEXT OF RELEVANT DISEASE.

SO WE DON'T WANT TO DEVELOP THEM IN A VACUUM, AND

THAT'S REALLY THE MULTIDISCIPLINARY COLLABORATIVE

PIECES THAT WE'RE LOOKING FOR.

MS. SAMUELSON: YOU GET GOOD EXPERTISE

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FROM THE WORKING GROUP, BUT THAT'S KIND OF LATE IN

THE PROCESS.

DR. COLLINS: ACTUALLY PAT'S REMINDED ME

OF AN OUTCOME THAT WE'VE HAD FROM ONE OF OUR TOOLS

AND TECHNOLOGIES GRANTS, AND THAT'S DR. LIM'S WORK

TO DELIVER CELLS IN THE BRAIN. IT'S BEEN A VERY

SUCCESSFUL AWARD. AND WE'VE HAD, YOU KNOW, SOME

ADDITIONAL TECHNOLOGIES GETTING A LOT OF UPTAKE,

INCLUDING SOME WORK BY DR. LORING, WHO'S DEVELOPED A

TOOL THAT'S HAD THOUSANDS OF USES SO FAR.

WE'VE HAD ANOTHER GRANTEE DEVELOP A DEVICE

THAT'S BEEN USED FOR SOME IMAGING. AND AS A RESULT

OF THAT TOOLS AND TECHNOLOGIES I AWARD, WE'VE HAD A

CONTRACT WITH THE FDA AND A LARGE PHARMACEUTICAL.

JUST REMINDING YOU OF SOME OF THE OUTCOMES PRIOR. I

REALLY DO THINK THAT THIS HAS THE POTENTIAL TO HELP

THE NEURODEGENERATION EFFORT AND PERSONALLY ALSO THE

CARDIOVASCULAR, A NUMBER OF FIELDS.

MS. SAMUELSON: THE QUESTION IS GETTING

HARDER FOR ME TO ANSWER. WHAT IS THE BEST USE OF

THE MONEY? HOW DO WE TRIAGE BECAUSE WE'RE RUNNING

OUT OF MONEY? AND MY HUNCH, MY STRONG HUNCH, IS

THAT WE WILL BE ABLE TO GET SUPPLEMENTAL FUNDING IF

WE HAVE MADE PEOPLE BETTER. SOME PEOPLE IN SOME

ENVIRONMENT WHERE THEY HAVE BEEN STRUGGLING AND OUR

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MONEY GAVE THEM ANOTHER CHANCE. AND SO THAT'S MY

QUESTION, AND IT'S SORT OF NOT ON THE POINT, BUT YET

IT IS.

CHAIRMAN THOMAS: I THINK, JOAN, MY

COMMENT WOULD BE THAT I SORT OF VIEW TOOLS AND

TECHNOLOGIES AS A CRITICAL ENABLING RFA THAT CAN

HAVE IMPACT OVER A WIDE RANGE OF DIFFERENT RESEARCH

PROJECTS. AND IT REALLY IS AMONGST THE MOST

VALUABLE THAT WE HAVE BECAUSE IT DOES HAVE A LOT OF

APPLICATION DOWNSTREAM THAT ALLOWS PEOPLE TO GET

INTO TRANSLATION, ETC. SO I THINK THIS IS VERY,

VERY VALUABLE.

OKAY. OTHER COMMENTS BY MEMBERS OF THE

BOARD? COMMENTS BY MEMBERS OF THE PUBLIC? COMMENTS

BY ANYBODY ON THE PHONE? OKAY. THANK YOU. MARIA,

WILL YOU PLEASE CALL THE ROLL.


DR. BERGLUND: AYE.


DR. BRENNER: YES.


DR. DULIEGE: AYE.


MS. FEIT: YES.


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DR. FINE: YES.


DR. FRIEDMAN: YES.


HAWGOOD.

DR. HAWGOOD: YES.



LLOYD MINOR.

DR. MINOR: YES.


DR. PRIETO: AYE.


DR. PULIAFITO: YES.


DR. QUINT: YES.


MR. ROWLETT: YES.


MS. SAMUELSON: YES.


MR. SHEEHY: YES.


DR. STEWARD: YES.


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MR. TORRES: AYE.


DR. VUORI: YES.


WINOKUR.

MS. WINOKUR: YES.

CHAIRMAN THOMAS: OKAY. MOTION PASSES.

THANK YOU VERY MUCH.

ITEM NO. 9, CONSIDERATION OF THE EXTENSION

OF AN ALLOCATION OF ADDITIONAL FUNDS FOR RESEARCH

LEADERSHIP PROGRAMS. DR. YAFFE.

DR. YAFFE: MR. CHAIRMAN, MEMBERS OF THE

BOARD, MEMBERS OF THE PUBLIC, I BRING FOR YOUR

CONSIDERATION TODAY AN EXTENSION OF THE RESEARCH

LEADERSHIP AWARDS PROGRAM. JUST TO REMIND YOU, AND

FOR THOSE NEW BOARD MEMBERS, LET ME BRIEFLY TOUCH ON

THE GOALS AND FEATURES OF THAT PROGRAM WHICH HAS

BEEN ONGOING.

THE GOALS INCLUDE TO FACILITATE THE

RECRUITMENT TO CALIFORNIA OF THE MOST PRODUCTIVE AND

PROMISING EARLY TO MIDCAREER SCIENTISTS IN STEM CELL

BIOLOGY AND REGENERATIVE MEDICINE. AND FOLLOWING

THEIR SUCCESSFUL RECRUITMENT, TO SUPPORT THEIR

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ROBUST AND INNOVATIVE RESEARCH PROGRAMS FOCUSED ON

FUNDAMENTAL STUDIES OF PLURIPOTENT AND PROGENITOR

STEM CELL BIOLOGY AND ON TRANSLATIONAL STUDIES

LEADING TO INNOVATIVE STEM CELL-BASED THERAPIES FOR

DISEASE AND INJURY.

THIS PROGRAM HAS BEEN OPEN TO NONPROFIT

CALIFORNIA INSTITUTIONS, HAS HAD THE CONDITION THAT

A CANDIDATE OR PI MUST HOLD A POSITION OUTSIDE

CALIFORNIA AND HAVE BEEN INDEPENDENT FOR AT LEAST

THREE YEARS AT THE TIME OF THE APPLICATION. AND

THAT INDIVIDUAL INSTITUTIONS COULD RECEIVE ONLY A

SINGLE RESEARCH LEADERSHIP AWARD.

THE AWARD FEATURES, THE PREVIOUS AWARDS

THAT YOU HAVE MADE HAVE PROVIDED FUNDS TO SUPPORT

RESEARCH FOR UP TO SIX YEARS. WE'RE PROPOSING FOR

THIS EXTENSION THE AWARDS WILL SUPPORT RESEARCH FOR

FIVE YEARS. AWARDEES MUST COMMIT AT LEAST 75

PERCENT OF THEIR TIME TO STEM CELL OR REGENERATIVE

MEDICINE RESEARCH. AND ELIGIBLE COSTS INCLUDE THE

PI'S SALARY, LAB OPERATIONS, LAB RELOCATION COSTS,

EQUIPMENT, WHICH MUST BE MATCHED ONE TO ONE BY FUNDS

FROM THE INSTITUTION, AND APPROPRIATE FACILITIES AND

INDIRECT COSTS.

HERE IS OUR SCORECARD ON THIS PROGRAM TO

DATE. YOU HAVE APPROVED 11 AWARDS. OF THOSE, FIVE

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HAVE BEEN ACCEPTED. THREE AWARDS ARE PENDING

CURRENTLY. I'LL SAY SOMETHING ELSE ABOUT THAT IN A

MOMENT. THREE AWARDS WERE DECLINED.

THIS IS A LIST OF THE RESEARCH LEADERSHIP

AWARDS MADE TO DATE. THREE OF THESE ARE ACTIVE.

TWO OF THEM HAVE BEEN ACCEPTED. THIS IS FROM THE

MOST RECENT ROUND THAT YOU APPROVED. AND THOSE

AWARDS ARE IN PREFUNDING ADMINISTRATIVE REVIEW

CURRENTLY, AND FUNDS WILL START FLOWING VERY SOON.

AND THEN FOR THREE AWARDS, THE RECRUITMENT IS STILL

IN PROGRESS. WE ARE HOPEFUL. WE DON'T KNOW THAT

ALL THREE WILL BE LANDED, BUT WE'RE HOPEFUL THAT AT

LEAST SEVERAL OF THESE WILL COME TO CALIFORNIA.

THIS IS A FAIRLY NEW PROGRAM WITH REGARD

TO TRACK RECORD. AS YOU SAW, THERE ARE ONLY THREE

ACTIVE AWARDS WHERE FUNDS HAVE BEEN DISBURSED AND

PEOPLE ARE ACTUALLY WORKING. BUT I JUST WANT TO

REPORT TO YOU SOME PRELIMINARY OUTCOMES ON THOSE

THREE AWARDS. THOSE THREE AWARDS HAVE RESULTED IN

THE HIRING OF 30 NEW RESEARCH PERSONNEL OR THE

RELOCATION OF THESE PERSONNEL TO CALIFORNIA.

THEY'VE BROUGHT IN MORE THAN $2.1 MILLION IN

ADDITIONAL RESEARCH FUNDS TO CALIFORNIA. THIS IS

GRANTS BROUGHT BY THE SCIENTISTS WHO WERE RECRUITED

TO CALIFORNIA FROM AGENCIES AND PRIVATE FOUNDATIONS.

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THEY'VE LED TO NOVEL RESEARCH DIRECTIONS UNDERTAKEN

BY THESE CANDIDATES AND AN INCREASED FOCUS IN

PARTICULAR ON TRANSLATIONAL RESEARCH. THEY'VE LED

TO NEW COLLABORATIONS WITH CALIFORNIA SCIENTISTS AND

SUPPORT FOR HIGH RISK, HIGH IMPACT PROJECTS, IN AN

ENHANCED LEVERAGING OF INSTITUTIONAL RESOURCES.

OUR PROPOSAL TO YOU IS TO EXTEND THE

RESEARCH LEADERSHIP PROGRAM FOR ONE ADDITIONAL

APPLICATION CYCLE AND TO FUND UP TO FOUR ADDITIONAL

AWARDS. THE GOAL OF THIS EXTENSION IS TO BRING

ADDITIONAL EXCEPTIONAL STEM CELL SCIENTISTS TO

CALIFORNIA TO STRENGTHEN AND SYNERGIZE WITH OTHER

EFFORTS TO BUILD UP LOCAL SUSTAINED RESEARCH

COMMUNITIES AND TO PROVIDE OPPORTUNITIES FOR

ADDITIONAL CALIFORNIA INSTITUTIONS TO PARTICIPATE IN

THIS PROGRAM AND RECRUIT LEADERS IN REGENERATIVE

MEDICINE.

YOU'VE PREVIOUSLY VOTED TO AWARD AND FUNDS

ARE PENDING OF UP TO $46 MILLION. WE'RE ASKING FOR

ADDITIONAL FUNDS TO SUPPORT FOUR MORE AWARDS AT $23

MILLION.

A PROVISIONAL TIMETABLE, SHOULD YOU

APPROVE THIS, IS THAT THIS ONE APPLICATION ROUND

WOULD HAVE APPLICATIONS DUE IN JANUARY, HOPEFULLY

GIVING ADEQUATE TIME FOR INSTITUTIONS TO IDENTIFY

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CANDIDATES AND BEGIN THE RECRUITMENT PROCESS. THE

GRANTS WORKING GROUP WOULD REVIEW THESE APPLICATIONS

IN MARCH OR APRIL, AND WE WOULD BRING RECOMMENDED

APPLICATIONS TO YOU FOR YOUR CONSIDERATION IN MAY.

IN SUMMARY, WE REQUEST BOARD APPROVAL FOR

AN EXTENSION OF THE RESEARCH LEADERSHIP AWARDS

PROGRAM FOR ONE ADDITIONAL APPLICATION CYCLE TO FUND

UP TO FOUR ADDITIONAL AWARDS WITH AN INCREASED

BUDGET ALLOCATION OF UP TO $23 MILLION. I'D BE VERY

HAPPY TO TAKE YOUR QUESTIONS.


DR. STEWARD: JUST CURIOUS. WHY ONLY ONE

CYCLE?

DR. YAFFE: WELL, PART OF IT, I THINK, HAS

TO DO WITH THINKING ABOUT HOW LONG THESE AWARDS WILL

GO, HOW LONG THE AGENCY MAY CONTINUE FUNCTIONING.

WE NEED TO HAVE ADEQUATE ADMINISTRATIVE OVERSIGHT TO

MONITOR THE AWARDS. AND I MAY BE THE LAST PERSON

OUT THE DOOR IF I'M IN CHARGE OF THIS, BUT HOPEFULLY

IT WON'T COME TO THAT. BUT I THINK WE'RE MINDFUL OF

THE CONSTRAINTS ON FUNDS AND THE TIMELINE OF THE

AGENCY.

DR. STEWARD: I ASKED THE QUESTION BECAUSE

THE JANUARY TIMELINE IS AWFULLY FAST GIVEN THAT

WE'RE JUST ANNOUNCING THIS. AND WE'VE SEEN HOW LONG

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IT ACTUALLY TAKES TO MAKE THESE THINGS HAPPEN OVER

THE COURSE OF THE EXISTENCE OF WHATEVER, TWO YEARS

OF THESE.

DR. YAFFE: THREE YEARS.

DR. STEWARD: JUST TO SAY THAT SEEMS

AWFULLY FAST.

DR. YAFFE: APPRECIATE THAT. WERE AN

AWARD MADE IN MAY OF NEXT YEAR, IT'S UNLIKELY THE

BODY WOULD ACTUALLY BE HERE IN CALIFORNIA BEFORE

PERHAPS THE END OF 2014, BEGINNING OF 2015. IF

WE'RE TALKING FIVE YEARS, THEN WE'RE OUT TO 2020.

YOU CAN SEE THE PROBLEM.

DR. TROUNSON: SO, OS, JUST A LITTLE BIT

OF CONTEXT AS WELL. WE GOT A LOT TO COME IN THE

LAST ROUND, AS YOU RECALL. AND THE INSTITUTIONS

HAVE BEEN TALKING TO ME BROADLY, THOSE THAT DON'T

HAVE THEM OR THOSE THAT HAVE THEM AND PENDING, AND

ESSENTIALLY SAID, WELL, IF YOU HAVEN'T GOT OFF THE

BOOKS BY OCTOBER, YOU CAN'T COME IN AT ALL. SO YOU

EITHER HAVE TO GET THEM IN OR YOU'RE OUT. BUT

THERE'S QUITE A LOT OF THESE INSTITUTIONS WHO HAVE

BEEN NEGOTIATING AND SAY WE'RE NEARLY THERE. WE

WANT TO COME NOW, AND, YOU KNOW, WE HAVEN'T HAD A

CHANCE. AND SO CAN YOU GIVE US ANOTHER CHANCE?

THAT'S REALLY WHERE IT ORIGINATES FROM.

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I THINK THERE ARE A NUMBER OF INSTITUTIONS

THAT ARE REASONABLY READY TO BRING SOMETHING. SO WE

THOUGHT, WELL, WE'VE DONE REASONABLY WELL TO THIS

POINT, BUT WE THOUGHT PERHAPS, IF THE BOARD FELT SO,

THAT ANOTHER FOUR WOULD REALLY ACCOMMODATE A FEW

MORE OF THE INSTITUTIONS THAT ARE REALLY WANTING

THESE BADLY, BUT NOT TO SORT OF PROLONG IT TOO LONG.

CHAIRMAN THOMAS: DEAN BRENNER.

DR. BRENNER: SO I'M VERY SYMPATHETIC WITH

THE DIFFICULTY IN THIS TYPE OF RECRUITMENT. SO I'M

IN FAVOR OF THIS. BUT I'M NOT SURE OF THE MATH.

THIS SEEMS LIKE THERE ARE THREE THAT ARE IN PLAY.

IF THEY DON'T WORK OUT, ARE YOU ASKING FOR SEVEN?

ARE YOU ASKING --

DR. YAFFE: IT'S A GOOD POINT. IF THOSE

THREE DON'T WORK OUT, WE'RE NOT GOING TO SPEND ALL

THE MONEY. THE MONEY IS GOING TO COME BACK. THE

REQUEST IS MADE AT THIS POINT TODAY WITH OUR

UNDERSTANDING RIGHT NOW OF WHERE THINGS ARE. IF

NONE OF THOSE THREE COME IN, WE PROBABLY MAY NOT

EXCEED THE MONEY THAT'S ALREADY BEEN APPROVED FOR

THIS PROGRAM. SO IT'S UNLIKELY WE WILL SPEND ALL

THE MONEY, AND THE MONEY IS NOT GOING TO GO AWAY.

IT'S GOING TO COME BACK INTO THE RESEARCH POOL.

MS. SAMUELSON: IS THAT HUNCH BASED ON

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THE, FOR A WHILE THERE, THE SCARCITY OF APPLICANTS?

IT COULD JUST GET BUSY AGAIN, RIGHT? I THINK IT'S A

GREAT PROGRAM.

DR. YAFFE: MY PERSONAL OPINION IS IT'S

GOING TO BE DIFFICULT TO LAND ALL THE CANDIDATES.

AS I'M SURE MANY OF THE ADMINISTRATORS AROUND THE

ROOM AND DEANS CAN TELL YOU, ACADEMIC RECRUITMENT IS

A REALLY FORMIDABLE CHALLENGE. SO THAT'S JUST AN

ESTIMATION THAT WE'RE NOT GOING TO LAND EVERYONE

WHO'S OFFERED SUCH A POSITION.

DR. TROUNSON: THERE'S BEEN SOME

TREMENDOUS CO-OFFERS TO THESE PEOPLE TO EITHER KEEP

THEM THERE OR MOVE THEM SOMEWHERE ELSE. SO WITHOUT

NAMING NAMES, YOU COULD WELL IMAGINE MAYBE WHERE

SOME OF THESE COME FROM. SO THE COMPETITION FOR

THESE KEY PEOPLE IS VERY, VERY HIGH. SO THAT'S

PARTLY WHY IT'S DIFFICULT FOR THE INSTITUTIONS TO

LAND THEM BECAUSE ONCE THEY GET TO KNOW THAT THEY'RE

INTERESTED IN MOVING, THERE'S A LOT OF COMPETITION

FOR THOSE PARTICULAR PEOPLE.

CHAIRMAN THOMAS: DO WE HEAR A MOTION?

MR. TORRES: SO MOVED.

CHAIRMAN THOMAS: MOVED BY SENATOR TORRES.

IS THERE A SECOND?

MS. SAMUELSON: I'LL SECOND IT.

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CHAIRMAN THOMAS: SECOND BY JOAN.

MS. SAMUELSON: AND I HAVE A COMMENT TO

MAKE AT WHATEVER POINT THAT'S APPROPRIATE.

CHAIRMAN THOMAS: OKAY. HOLD ON ONE

SECOND. MR. SHEEHY.

MR. SHEEHY: I JUST WANTED TO SPEAK TO THE

MOTION. SO I'M GOING TO VOTE AGAINST THIS. THIS IS

EXACTLY -- I MEAN THESE INDIVIDUALS ARE HONESTLY

PROBABLY NOT GOING TO START WORKING TILL SOMETIME IN

2015. YOU KNOW, I REALLY THINK WE HAVE TO MAKE SOME

DECISIONS ABOUT THEY'RE NOT GOING TO MEANINGFULLY

IMPACT THE COURSE OF THIS FIRST PHASE OF PROP 71.

AND, YOU KNOW, I THINK THIS IS -- WE HAVEN'T REALLY

HAD THIS DISCUSSION, BUT YOU MAY BE TRADING OFF YOUR

TRAINING PROGRAMS FOR ANOTHER ROUND OF RECRUITMENT.

WE MAY BE TRADING OUT THE BRIDGES PROGRAM FOR

ANOTHER ROUND OF RECRUITMENT.

IN THE ABSENCE OF THAT DISCUSSION, IF IT

WERE ME, I WOULD PREFER TO SEE OUR TRAINING PROGRAMS

CONTINUE. I WOULD PREFER TO SEE OUR BRIDGES PROGRAM

CONTINUE MYSELF BECAUSE I THINK THAT WE'RE GOING TO

END UP HAVING ALLOCATED ALL THE MONEY THAT WE -- AT

LEAST, AS I UNDERSTAND OUR STRATEGIC PLAN, EVEN

UNDER SCENARIO 2, WE HAD PLANNED TO ALLOCATE FOR

THIS TRAINING AND DEVELOPMENT CATEGORY, AND I

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JUST -- I JUST -- I DON'T KNOW. WE'RE NOT ADDING

ANY NEW CAPACITY TO THE FIELD. THESE INDIVIDUALS

ARE ALREADY WORKING IN STEM CELL SCIENCE. SO WE

HAVEN'T CREATED ANYTHING NEW.

I LOOK AT THIS, WE'RE PROBABLY CREATING A

LITTLE BIT OF INFLATION ACROSS THE BOARD IN STEM

CELL SCIENTISTS. IT'S LIKE THE NEW YORK YANKEES,

RIGHT? AND THE OTHER PART OF IT -- BUT IF YOU GO

TO -- IF YOU REALLY LOOK AT THIS WITH 30,000 FEET,

IN SOME WAYS IT'S NOT EVEN BENEFICIAL TO THE FIELD

BECAUSE YOU'RE TAKING THESE FOLKS OUT OF THEIR LABS

FOR A YEAR, RIGHT, SO THAT THEY CAN PACK UP AND

MOVE. I MEAN TO MY MIND THIS IS ONE OF THE -- YOU

KNOW, THERE WAS A TIME WHEN THIS WAS USEFUL BECAUSE

WE BUILT NEW BUILDINGS, WE NEEDED TO POPULATE THOSE

BUILDINGS, WE HAD A LOT OF MONEY TO SPEND, AND I

THINK WE WERE RUNNING INTO CAPACITY LIMITS AND THE

ABILITY TO ABSORB THE FUNDS THAT WE HAD IN TERMS OF

GETTING GOOD SCIENCE.

NOW WE'RE SITTING ANTICIPATING SCARCITY.

AND FOR ME MY BIAS IS TOWARDS SUSTAINING VITAL

INFRASTRUCTURE, SO PROGRAMS THAT WE'VE ALREADY

DEVELOPED AND SEEING THAT WE CAN CONTINUE THOSE AS

FAR AS OUT AS WE CAN PENDING ANOTHER SOURCE OF

MONEY, AND IDENTIFYING THE BEST SCIENCE THAT WE HAVE

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IN THE TRANSLATIONAL AND CLINICAL SPACE, AND MAKING

SURE THAT WE CAN SUPPORT THAT ALL THE WAY THROUGH.

SO WHERE ALPHA CLINICS SEEMS RIGHT ON THE

SPOT, THIS SEEMS LIKE A DISTRACTION. AND THERE ARE

OPPORTUNITY COSTS TO REVIEWING THIS. THERE ARE

OPPORTUNITY COSTS TO PROGRAMS BEING ENGAGED IN THIS

ACTIVITY. SO IT'S NOT LIKE MAYBE NOBODY GETS IT OR

WHAT HAVE YOU. SO I JUST -- I THINK THIS IS KIND OF

A DEVIATION FROM OUR MISSION OR WHERE I WOULD HAVE

THOUGHT OUR MISSION WOULD BE AT THIS STAGE IN OUR

DEVELOPMENT AND WHAT I WOULD HAVE THOUGHT -- WHAT I

TOOK TO BE WHERE WE WERE COMING OUT OF OUR APPROVAL

OF THE STRATEGIC PLAN LAST FALL. THIS WAS NOT A

PROGRAM I WOULD HAVE THOUGHT WOULD HAVE APPEARED

ANYWHERE IN THERE. SO...

CHAIRMAN THOMAS: JOAN.

MS. SAMUELSON: COUNTERPOINT. WE USUALLY

AGREE ON EVERYTHING, SO THIS IS SURREAL. I

THINK -- WELL, AND IT COMES FROM MY PERSPECTIVE FROM

NEURODEGENERATIVE DISEASES. AND YOU MIGHT NOT BE

ABLE TO IMAGINE HOW DEAD IN THE WATER IT FEELS IN

THAT AREA. AUTISM, NOTHING. IN PARKINSON'S, ALS.

PARKINSON'S WE WERE ALL SAYING FIVE TO TEN YEARS 20

YEARS AGO, AND WE COULDN'T GET A DISEASE TEAM GOING.

AND I THINK WHAT THE FIELD NEEDS FOR PARKINSON'S,

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JUST AS ANOTHER EXAMPLE, ARE FRESH IDEAS, BRILLIANT

IDEAS THAT MOVE -- CHANGE THE PARADIGM AND JUST

CHANGE AND REENERGIZE THE SCIENCE. AND THAT'S NEW

BRILLIANT MINDS COMING IN AND COLLABORATING, I

THINK. AND THAT'S WHAT THIS DOES.


DR. STEWARD: JUST TO ENDORSE, AMPLIFY

WHAT JOAN SAYS, I THINK IT'S UNBELIEVABLE WHAT THIS

PROGRAM HAS ACCOMPLISHED OVER THE EIGHT PLUS YEARS

THAT IT'S BEEN GOING. AND UNBELIEVABLE IN

PARTICULAR BECAUSE WHEN YOU THINK ABOUT IT, WHAT

EXISTED BACK THEN WAS VERY FEW PEOPLE DOING STEM

CELLS, AND WE ESSENTIALLY RETOOLED OUR SCIENTIFIC

COMMUNITY HERE IN CALIFORNIA. THERE WERE A LOT OF

PEOPLE WHO WERE EXPERTS IN RELATED THINGS, BUT NOT

VERY MANY PEOPLE WHO WERE EXPERTS IN STEM CELLS.

IT'S NOTEWORTHY THAT ALL THIS HAS BEEN

ACCOMPLISHED LARGELY ON THE BACKS OF CALIFORNIA

SCIENTISTS WITH ONLY REALLY THREE ADDITIONS THROUGH

THIS PROGRAM. BUT CALIFORNIA ISN'T THE WORLD, AND

THERE IS A LOT OF TALENT OUT THERE THAT CAN STILL BE

RECRUITED AND BROUGHT INTO THIS. AND I THINK IT'S

IMPORTANT TO DO THIS IN TIMES OF SCARCITY AS WELL AS

IN TIMES OF ABUNDANCE. MAYBE EVEN MORE SO IN TIMES

OF SCARCITY BECAUSE THESE EXPERTS OUT IN THE OTHER

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AREAS ARE NOT GOING TO BE ABLE TO HAVE THE RESOURCES

FROM NIH OR OTHER FUNDING SOURCES THAT WE CAN STILL

PROVIDE. THE PROGRAMS THAT ARE IN EXISTENCE HERE

ARE GOING STRONG ACTUALLY.

WE HEARD THAT EACH OF THESE PEOPLE, THESE

THREE BROUGHT IN ABOUT AN AVERAGE OF TEN, SO 30

PEOPLE NOW ENGAGED IN THESE LABS. THAT'S A HUGE

BOOST TO THE ENTERPRISE. SO I THINK IT'S MONEY WELL

SPENT. I ALWAYS THINK IT'S MONEY WELL SPENT WHEN

YOU'RE BRINGING IN NEW EXPERTISE.

CHAIRMAN THOMAS: DR. PRIETO, DID I SEE

YOUR HAND UP OVER THERE?

DR. PRIETO: YEAH. I FIND IT A LITTLE

STRANGE TO FIND MYSELF DISAGREEING WITH JOAN AND OS,

BUT I HAVE TO AGREE WITH JEFF HERE, THAT I THINK

WE'VE DISCUSSED THIS IN DISCUSSING THE STRATEGIC

PLAN IN SORT OF GENERAL TERMS, BUT THIS IS WHERE THE

RUBBER MEETS THE ROAD. AND WE'RE LOOKING AT

ACTUALLY SPENDING A LARGE CHUNK OF MONEY THAT WILL

NOT BE SPENT ON SOMETHING ELSE, AND WE'RE COMING UP

AGAINST HARD DEADLINES AND FINITE RESOURCES. SO

THIS MONEY IS MONEY THAT WE WILL NOT BE ABLE TO

DEVOTE TO OTHER THINGS.

I THINK THAT WE HAVE CERTAINLY ATTRACTED

SOME OUTSTANDING PEOPLE TO CALIFORNIA, BUT I THINK

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WE WILL CONTINUE TO DO THAT EVEN WITHOUT THIS

PROGRAM. AND I JUST THINK THERE ARE BETTER WAYS

RIGHT NOW FOR US TO SPEND OUR MONEY.

CHAIRMAN THOMAS: DIANE.

MS. WINOKUR: WE HAVE RECRUITED

SUCCESSFULLY AND WE HAVE ALSO TRAINED A NEW

GENERATION OF STEM CELL SCIENTISTS. I THINK IT'S

IMPORTANT THAT INSTITUTIONS MAKE USE OF THE ONES

WE'VE TRAINED LOCALLY STATEWIDE. AND I'M AWARE THAT

THE INSTITUTIONS ARE DOING RECRUITING ON THEIR OWN

COMPLETELY WITHIN THE INSTITUTION. AND I ALSO KNOW

THAT SCIENTISTS ARE MOVING HERE BECAUSE OF CIRM

WITHOUT OUR DOING ANYTHING TO BRING THEM. AND SO I

WOULD PREFER THAT WE SPEND THE MONEY ON SOME OF OUR

OTHER PROJECTS LIKE INDIVIDUAL RESEARCH PROPOSALS,

ANY OF OUR INDIVIDUAL PROJECT PROPOSALS.

CHAIRMAN THOMAS: DEAN PULIAFITO.

DR. PULIAFITO: I STRONGLY ENDORSE

EXTENDING THE PROGRAM. I'VE SEEN THIS FIRSTHAND.

WE GOT ANDY MCMAHON, WHO IS CHAIRMAN OF THE BIOLOGY

DEPARTMENT AT HARVARD, TO LEAVE. NOW USC PUT A LOT

OF MONEY INTO THIS RECRUITMENT, BUT YOU KNOW WHAT,

THE RESEARCH LEADERSHIP AWARD REALLY HELPED. AND IN

THE END, IT REALLY IS ABOUT THE PEOPLE THAT WE HAVE

IN THE COMMUNITY. SO IF ALAN TELLS US THAT THERE

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ARE INSTITUTIONS THAT HAVE LINED UP SOME GOOD FOLKS,

THEN I THINK THAT THIS IS A GOOD THING TO VOTE FOR.

DR. TROUNSON: SO, CHAIR, THE CONTEXT IS

THIS IS ONE DISEASE TEAM OR SLIGHTLY MORE, ONE

DISEASE TEAM. THESE ARE POWERHOUSE PEOPLE. THEY

REALLY ARE. I THINK YOU CAN ASK A LOT OF THE GRANTS

WORKING GROUP AND OTHER PEOPLE. THOSE PEOPLE WHO

DELIVER IN THIS AREA CONTINUE TO DELIVER. YOU'RE

BACKING A PERSON. I JUST ENCOURAGE THE BOARD TO

THINK ABOUT THIS BECAUSE I JUST -- I KNOW IN SEVERAL

CASES THAT THIS WILL MAKE A REALLY BIG DIFFERENCE IF

THEY CAN GET THESE PEOPLE TO COME. IF NOT, WELL,

YOU KNOW, THEY WILL FOREGO IT AND WHATEVER LIFE WILL

BE LIFE.

BUT THESE ARE POWERHOUSE PEOPLE. IF YOU

LOOK AT THEM, ONE OR TWO OF THOSE PEOPLE WHO ARE NOT

FAR OFF A NOBEL PRIZE THAT ARE ON THAT LIST. THESE

ARE REALLY POWERHOUSE PEOPLE WHO WILL MAKE A HUGE

DIFFERENCE FOR A LIFETIME IN CALIFORNIA. SO I THINK

IT'S WORTH THINKING ABOUT THAT. I REALLY DO. AND

IN THE END WE'RE JUST SAYING, LOOK, WE THINK ONE

MORE ROUND, THERE MIGHT ONLY BE SIX OR SEVEN OF THEM

UP UNTIL NOW, ONE MORE ROUND OF THIS, THIS IS YOUR

LAST CHANCE, FOR EXAMPLE, AND WOULD BE REALLY,

REALLY WORTHWHILE FOR CALIFORNIA. SO I'D LIKE YOU

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TO THINK CAREFULLY WHEN YOU COME TO VOTE ON IT

BECAUSE I THINK IT'S VERY, VERY IMPORTANT FOR THE

LONGEVITY OF CALIFORNIA IN THIS SPACE.

CHAIRMAN THOMAS: CARMEN, QUESTION FOR

YOU. WHEN ANDY CAME OUT, DID HE BRING OTHERS WITH

HIM AND HOW MANY?

DR. PULIAFITO: HE BROUGHT -- HE CLEANED

OUT HIS LAB AT HARVARD. SO THERE ARE 15 SCIENTISTS

THAT CAME. AND I SHOULD ALSO POINT OUT WE'VE

JUST -- WE MADE SUBSTANTIAL INVESTMENT. SO WE'RE

JUST STARTING TO RECRUIT THREE OTHER STEM CELL

SCIENTISTS DIRECTLY ASSOCIATED WITH HIM HE'S

RECRUITED FROM ACROSS THE COUNTRY AND TURNING DOWN

OFFERS AT PRESTIGIOUS PLACES ELSEWHERE. I MEAN THIS

IS SHORT MONEY TO ME COMPARED TO THE WAY WE SPEND

MONEY HERE.

CHAIRMAN THOMAS: SO YOUR POINT WOULD BE

THAT YOU'RE NOT ONLY GETTING THE PERSON, BUT THERE'S

A BIG MULTIPLIER EFFECT OF SUBSTANTIAL TALENT THAT

COMES ALONG WITH THAT PERSON. OKAY.

MR. ROWLETT.

MR. ROWLETT: ONE OF THE THINGS THAT'S A

BIT CONFUSING ABOUT THIS IS JUST THE IMPLICATIONS OF

THE LOST OR THE OPPORTUNITY COST ASSOCIATED WITH

THIS EFFORT. AND WHAT WE WILL REALIZE, IN ALL DUE

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RESPECT TO EVERYBODY, WHAT WE REALIZE LONG-TERM FROM

THESE RECRUITMENT EFFORTS. SO I'M GOING TO ABSTAIN

FROM THE VOTE BECAUSE I DON'T HAVE A FULL

APPRECIATION OF THAT.

IF I WERE TO MAKE A SUGGESTION, IT WOULD

BE VERY HELPFUL FROM AN ADVOCATE'S PERSPECTIVE TO

GET -- TO SOMEHOW INCORPORATE THE PATIENT'S VIEW

INTO THESE PRESENTATIONS. IT IS INFLUENTIAL IN

MAKING A DECISION WHEN PATIENTS CAN TALK ABOUT WHAT

THESE SCIENTISTS THAT YOU FOLKS HAVE BROUGHT IN,

WHAT THEY HAVE DONE IN TERMS OF STEM CELL RESEARCH.

IT HELPS INFLUENCE, AND TYPICALLY THE PATIENTS SPEAK

IN TERMS OF PRACTICAL VALUE THAT THESE FOLKS HAVE

BROUGHT TO THE STATE OF CALIFORNIA IN THE AREA OF

STEM CELL RESEARCH. SO...

CHAIRMAN THOMAS: THANK YOU. JOAN.

MS. SAMUELSON: AND I'LL TRY TO BE QUICK.

THE BOARD HAS ALREADY SPENT A FAIR AMOUNT OF TIME ON

THE PROPOSED RESEARCH LEADERSHIP AWARD WHICH WAS

AWARDED TO THE PARKINSON'S INSTITUTE AND DENNIS

STEINDLER TO RECRUIT HIM. AND AS WE WERE TOLD,

WHENEVER IT WAS, THAT AWARD HAS FALLEN APART. I

THINK IT'S MOST IMPORTANT THAT THE BOARD BE AS

INFORMED ABOUT THAT AS IT WANTS TO BE AND DOESN'T

NECESSARILY NEED TO INQUIRE NOW. BUT I AM CONFIDENT

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THAT, AS I THINK WE ALL SAW AT THE TIME OF THE

AWARD, THIS WAS A TREMENDOUSLY EXCITING TEAM EFFORT,

AND IT INVOLVED TWO STELLAR -- A STELLAR INSTITUTION

AND A STELLAR INDIVIDUAL CANDIDATE. AND IT'S

CERTAINLY MY STRONG HOPE THAT WE CAN ASSIST THEM IN

FINDING PLACEMENT FOR BOTH, A RECRUITMENT FOR THE

PARKINSON'S INSTITUTE AND SOME OTHER WONDERFUL

PERSON TO MATCH THE EXCEPTIONAL QUALITY OF THE

PARKINSON'S INSTITUTE -- AND I CAN FILL YOU IN ABOUT

THE DETAILS OF THAT SINCE YOU WEREN'T AROUND IN THE

FIRST ROUND PROBABLY LATER -- AND GET THE LEAPS IN

SCIENCE THAT I WAS CONFIDENT WE WOULD GET WITH THAT

TEAM.

CHAIRMAN THOMAS: THANK YOU. DR. STEWARD.

DR. STEWARD: JUST ONE MORE QUICK POINT,

AND I REALLY WANTED TO JUST COMMENT ON WHAT DIANE

SAID. THE THING THAT IS IMPORTANT TO UNDERSTAND IS

THAT THESE PEOPLE ARE ACTUALLY REVIEWED ON THE BASIS

OF THEIR SCIENCE. THEY MAKE A PROPOSAL TO THE

GRANTS WORKING GROUP, AND IT'S REVIEWED JUST LIKE

ANY OF OUR OTHER GRANTS. SO IT IS REALLY FUNDING

RESEARCH TO BRING THESE PEOPLE ON, BUT IT'S FUNDING

RESEARCH THAT MAY OR MAY NOT BE POSSIBLE UNLESS

THOSE PEOPLE ARE ACTUALLY HERE.

AND JUST TO MENTION ONE OTHER THING, I

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THINK A LOT OF THESE RECRUITS ARE MADE ON THE BASIS

OF FILLING A NEED FOR SYNERGY, THAT YOU KNOW YOU

SOMETIMES HAVE A GREAT GROUP, BUT THERE'S THAT ONE

KEY PIECE MISSING OR SOME CRITICAL ABILITY THAT

WOULD JUST LAUNCH YOU IN TOTALLY NEW WAYS. SO

AGAIN, JUST TO SAY I THINK THAT THE PEOPLE ARE

REALLY THE MOST IMPORTANT RESOURCES.

MS. WINOKUR: LET ME BE SURE I UNDERSTAND

WHAT YOU SAID. YOU THINK THAT THESE OUTSTANDING

PEOPLE WILL NOT CONTINUE TO CONTRIBUTE TO STEM CELL

RESEARCH WHERE THEY ARE? THEY'RE MISSING SOMETHING?

DR. STEWARD: NO. I WOULDN'T SAY THAT AT

ALL. BECAUSE THESE ARE HARDWORKING PEOPLE, THEY'RE

GOING TO FIND A WAY TO GET SUPPORT, BUT WE'RE GOING

TO BE ABLE TO SUPPORT THEM BETTER FOR AT LEAST A

PERIOD OF TIME OUT HERE THAN THEY WOULD OTHERWISE.

AGAIN, I THINK THAT WE STILL ARE THE 600-POUND

GORILLA IN TERMS OF FUNDING STEM CELL SCIENCE.

CHAIRMAN THOMAS: OKAY. ARE THERE

COMMENTS FROM MEMBERS OF THE PUBLIC?

MR. REED: I SEE HIRING SOMEONE LIKE THIS

IS LIKE HIRING AN ENCYCLOPEDIA OF KNOWLEDGE.

THEY'RE PEOPLE THAT NOT ONLY KNOW EVERYTHING ABOUT

THE FIELD, BUT CAN PUT IT TOGETHER IN NEW WAYS, PLUS

THEY'RE BRINGING WITH THEM 15 OR 16 ALSO MINOR

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EXPERTS.

THERE WAS A PROGRAM ON NPR RECENTLY ABOUT

THE PRICE OF PROGRESS, AND IT SAID WHEN YOU BRING

PEOPLE TOGETHER, THE SYNERGY, THE MIND WAVES, THEIR

CONVERSATIONS, EVERYTHING ADDS UP TO PROGRESS, BUT

YOU HAVE TO BRING THEM TOGETHER. I THINK WE'RE AT A

UNIQUE SPOT IN HISTORY WHEN WE ARE BRINGING PEOPLE

TOGETHER. I'D LIKE US TO DO IT.

CHAIRMAN THOMAS: OTHER COMMENTS BY

MEMBERS OF THE PUBLIC? HEARING NONE, MARIA, PLEASE

TAKE THE ROLL.


DR. BERGLUND: YES.


DR. BRENNER: YES.


DR. DULIEGE: YES.


MS. FEIT: YES.


DR. FINE: YES.


DR. FRIEDMAN: YES.


HAWGOOD.

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DR. HAWGOOD: YES.



LLOYD MINOR.

DR. MINOR: YES.


DR. PRIETO: NO.


DR. PULIAFITO: YES.


DR. QUINT: NO.


MR. ROWLETT: ABSTAIN.


MS. SAMUELSON: YES.


MR. SHEEHY: NO.


DR. STEWARD: YES.




MR. TORRES: AYE.


DR. VUORI: YES.

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WINOKUR.

MS. WINOKUR: NO.

CHAIRMAN THOMAS: MR. HARRISON.

MR. HARRISON: THE MOTION PASSES BY A VOTE

OF 14 YES, FOUR NO, AND ONE ABSTENTION.

DR. YAFFE: THANK YOU.

CHAIRMAN THOMAS: THANK YOU, DR. YAFFE.

OKAY. ON TO THE NEXT ITEM, WHICH IS

CONSIDERATION OF APPOINTMENT OF NEW SCIENTIFIC

MEMBERS OF THE GRANTS WORKING GROUP. DR. SAMBRANO.

DR. SAMBRANO: THANK YOU, MR. CHAIRMAN,

MEMBERS OF THE BOARD, MEMBERS OF THE PUBLIC. WE'RE

COMING TO YOU TODAY WITH FIVE NOMINEES FOR

MEMBERSHIP FOR THE GRANTS WORKING GROUP. THE BIOS

AND NAMES OF THESE INDIVIDUALS ARE IN YOUR BOOKS. I

WILL NAME THEM FOR CONVENIENCE. THESE ARE BRENDA

ANDREWS, JOHN CENTANNI, ROBERT MARCUS, HASSAN

MOVAHHED, AND KELLY OTTO. AND THEY'RE BRINGING TO

US EXPERTISE IN THE AREAS OF SYSTEMS BIOLOGY,

GENOMICS, CLINICAL OPERATIONS, AND REGULATORY

AFFAIRS.

SO WE'RE SEEKING YOUR APPROVAL OF THESE

NOMINEES.

CHAIRMAN THOMAS: DO I HEAR A MOTION TO

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THAT EFFECT?

DR. HAWGOOD: SO MOVED.

CHAIRMAN THOMAS: MOVED BY DEAN HAWGOOD.

DR. PRIETO: SECOND.

CHAIRMAN THOMAS: SECONDED BY DR. PRIETO.

COMMENTS FROM MEMBERS OF THE BOARD? HEARING NONE,

COMMENTS BY MEMBERS OF THE PUBLIC? OKAY. I THINK

THIS DOES NOT REQUIRE A ROLL CALL VOTE. ALL THOSE

IN FAVOR PLEASE SAY AYE.

WAIT. WAIT. MR. HARRISON IS FURROWING

HIS BROW. IT'S NEVER A GOOD SIGN.

MR. HARRISON: FOR THOSE ON THE PHONE YOU

HAVE TO TAKE A ROLL CALL.

CHAIRMAN THOMAS: OKAY. SO IT'S A

SEMI-FURROW. OKAY. ALL THOSE IN FAVOR PLEASE SAY

AYE. OPPOSED? ON THE PHONE?

DR. FINE: AYE.

CHAIRMAN THOMAS: THANK YOU, DR. FINE.

MOTION CARRIES UNANIMOUSLY.

WE WILL NOW MOVE ON TO ITEM NO. 12 -- NO.

YES. ITEM NO. 12, CONSIDERATION OF ALLOCATION OF

ADDITIONAL FUNDS FOR A CONFERENCE GRANT PROGRAM FOR

FISCAL YEAR '13-'14. DR. TROUNSON.

DR. TROUNSON: THANK YOU VERY MUCH, CHAIR.

THE REPORTING ON THE CONFERENCE GRANT PROGRAM, WHICH

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WE'RE REQUIRED TO DO FROM TIME TO TIME, SO THIS IS

FOR THE TIME, THE APPROPRIATE TIME. SO JUST OVER

THE YEARS, IF I CAN GIVE YOU THE BREAKDOWN, 2008-9

TO 2012-13, THE NUMBER OF GRANTS THAT WE RECEIVED,

THE NUMBER -- THE AMOUNT OF DOLLARS THAT WERE

REQUESTED AND THE AMOUNT OF DOLLARS THAT WERE

AWARDED. AND IF YOU REMEMBER, WE HAVE TO REMAIN

WITHIN $300,000.

SO THE NUMBER OF GRANTS HAVE BEEN

PROGRESSIVELY GOING UP IN TIME, BUT WE'VE REMAINED

UNDER THAT $300,000. LAST YEAR THERE WERE 13

GRANTS. AND JUST TO GIVE YOU A BIT OF AN IDEA, THEY

WERE REALLY FROM VERY DIFFERENT PLACES WORKING TO

WALK SCIENCE AND ADVOCACY, 11TH ANNUAL GENE THERAPY

SYMPOSIUM FOR HEART, LUNG, AND BLOOD DISEASES, STEM

CELLS AND CRANIOFACIAL DEVELOPMENT OF DISEASE, CELL

THERAPIES IN TRAUMA AND CRITICAL CARE, BARRIERS TO

TRANSLATION FROM PRECLINICAL TO CLINICAL

DEVELOPMENT, THE ISSCR, RODDENBERRY INTERNATIONAL

SYMPOSIUM ON CELL REPROGRAMMING, CALIFORNIA ALS

SUMMIT, THE SANFORD CONSORTIUM FOR REGENERATIVE

MEDICINE, AND INVESTA PARTNERING ON STEM CELLS ON

THE MESA, THE 2013 RACHEL LEVINE DIABETES AND

OBESITY SYMPOSIUM, THE NEXT BEST STEPS, SETTING A

PATH FOR ADVANCING PEDIATRIC NEUROLOGY, USC

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FRONTIERS OF STEM CELLS AND AGING SYMPOSIUM, 2013

MATERIALS RESEARCH SOCIETY, DESIGN OF CELL

INSTRUCTIVE MATERIAL, THE 14TH UC SYSTEMWIDE

BIOENGINEERING SYMPOSIUM, CELL THERAPY FOR ALS,

TESTING THE LIMITS, WHAT SHOULD WE USE AS

PRECLINICAL STANDARDS THROUGH INITIATION OF CLINICAL

TRIALS.

SO THERE'S A REAL SPREAD ACROSS THE WHOLE

GAMUT. AND WHAT WE USUALLY DO IS WE MAKE A DECISION

ABOUT HOW MUCH STEM CELLS IS REALLY IN THERE, WHAT

CONTRIBUTION IT WOULD BE MAKING TO THE FIELD OF

INTEREST THAT WE'RE IN, AND THEY ALWAYS, NEARLY

ALWAYS, APPLY FOR VERY CLOSE TO $50,000, WHICH IS

THE LIMIT, BUT WE ADJUST IT TO MAKE GOOD SENSE OF

WHAT WE THINK THE PROGRAMS HAVE APPLIED FOR. SO

IT'S A BUSY PROGRAM AND IT'S BEEN VERY USEFUL AND

VERY WELL REGARDED.

SO THIS YEAR 2013-14 MOVING FORWARD IS A

LITTLE BIT OF A PROBLEM BECAUSE WHAT WE DID WAS WE

SAID, WELL, THERE'S A NUMBER OF REALLY KEY MEETINGS,

CONFERENCES THIS YEAR, THIS PARTICULAR YEAR. ONE OF

THEM IS A KEYSTONE STEM CELL AND REPROGRAMMING

CONFERENCE WHICH IS REALLY HEADED UP BY DEEPAK

SRIVASTAVA AND SHINYA YAMANAKA. AND SO WE, WITH

HELP FROM NATALIE DEWITT, WE ARE GOING TO BE RUNNING

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A SPECIAL SESSION IN THAT.

THE STEM CELLS ON THE MESA, WHICH IS A

REALLY IMPORTANT PROGRAM FOR OUR PARTNERING

COMPANIES AND THOSE STEM CELL DISEASE GROUPS THAT

ARE WORKING THEIR WAY UP INTO SUPPORT, THERE'S A

REGENERATIVE MEDICINE FOUNDATION HUMAN ORGAN

CONFERENCE EARLY NEXT YEAR.

AND THEN THE WORLD STEM CELL SUMMIT, WHICH

IS COMING BACK TO CALIFORNIA, WHICH IS A REALLY

LARGE CONFERENCE THAT WILL BE HELD IN SAN DIEGO.

AND THEN DUANE ROTH REMINDED US BIO WAS GOING TO BE

IN SAN DIEGO THIS YEAR -- SORRY -- NEXT YEAR. AND

SO IN THIS 2013-14 TIME FRAME. AND THAT BIO IS THE

BIGGEST MEETING IN BIOTECHNOLOGY IN THE COUNTRY, HE

FELT VERY STRONGLY WE SHOULD BE PART OF IT. I

ENDORSED THAT. I'VE BEEN AT THESE MEETINGS WHERE

WE'VE HAD A ROLE IN THOSE CONFERENCES, AND WE'VE

BEEN ABLE TO HAVE A SESSION WHERE WE'RE ABLE TO

INVITE A GROUP OF PEOPLE REALLY TO SHOW OFF WHAT

WE'RE DOING IN THE AREA. AND SO I'M SUPPORTIVE OF

THAT, BUT IT DOES COST US MONEY TO DO THOSE THINGS.

SO WITH THOSE KEY CONFERENCES, THERE'S A

COMMITMENT, IF WE'RE GOING TO GO FORWARD, OF AROUND

ABOUT 225,000, WHICH DOESN'T LEAVE MUCH FOR ALL OF

THOSE OTHER ONES I KIND OF DESCRIBED TO YOU. AND SO

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I WAS -- I THINK -- IT'S DIFFICULT TO ASK FOR MORE

FUNDS AT THIS POINT IN TIME IN THE BOARD MEETING,

BUT I THINK A ONE-OFF OF $50,000 WOULD HELP US MAKE

SURE THAT WE GOT SOME OF THOSE OTHER WORTHWHILE

CONFERENCES INCLUDED BECAUSE WE'RE REALLY DOWN TO

PERHAPS ONLY 75,000 FOR ALL OF THOSE OTHERS. SO I'D

LIKE TO RECOMMEND OR PUT A PROPOSAL TO YOU A ONE-OFF

EXTENSION TO THE CONFERENCE GRANTS OF $50,000. SO

IT WAS 350,000 FOR 2013-14 IF THERE'RE REALLY

MERITORIOUS CONFERENCE GRANT APPLICATIONS RECEIVED

IN ADDITION TO THOSE THAT WE THOUGHT ARE A PRIORITY

FOR 2013 AND 14.

MS. SAMUELSON: SO MOVED.

DR. PULIAFITO: SECOND.

CHAIRMAN THOMAS: MOVED BY JOAN, SECONDED

BY DEAN PULIAFITO. COMMENTS FROM MEMBERS OF THE

BOARD? DR. FINE, DO YOU HAVE A COMMENT BY ANY

CHANCE?

DR. FINE: NO COMMENTS.

CHAIRMAN THOMAS: THANK YOU. HEARING NO

COMMENTS, DO WE HAVE COMMENTS FROM MEMBERS OF THE

PUBLIC? NO COMMENTS. MR. HARRISON, CAN WE DO THIS

ON A VOICE VOTE? ALL THOSE IN FAVOR PLEASE SAY AYE.

OPPOSED? ABSTENTIONS? DR. FINE.

DR. FINE: AYE.

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CHAIRMAN THOMAS: THANK YOU. MOTION

PASSES.

OKAY. NOW GOING ON TO -- LET ME ASK A

QUESTION. IAN, HOW LONG DO YOU NEED FOR YOUR

PRESENTATION?

MS. BONNEVILLE: THREE HOURS.

CHAIRMAN THOMAS: THREE HOURS DOESN'T WORK

FOR ME. WHAT ELSE YOU GOT?

MR. SWEEDLER: FIFTEEN, 20 MINUTES

DEPENDING ON HOW MANY QUESTIONS THERE ARE.

CHAIRMAN THOMAS: OKAY. AND ALEX, HOW

LONG -- WE'RE TIMING THIS BECAUSE THERE ARE ICE

CREAM SANDWICHES --

MS. BONNEVILLE: THEY'RE HERE.

CHAIRMAN THOMAS: THEY'RE HERE. IT'S A

VERY IMPORTANT LINE OF QUESTIONING. LET'S PROCEED

TO IAN ON ITEM 14, AN UPDATE ON OUR COLLABORATIVE

FUNDING PARTNER PROGRAM.

DR. FINE: HOW ARE YOU GOING TO GET THE

ICE CREAM SANDWICH TO ME?

CHAIRMAN THOMAS: MICHAEL FRIEDMAN IS

FAXING IT. EVEN BETTER, HE'S 3D PRINTING IT TO YOU.

OKAY.

DR. FINE: THANK YOU.

CHAIRMAN THOMAS: I KNOW. SO IF THEY'RE

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HERE, MARIA, YOU'RE SAYING PEOPLE CAN AT THEIR

LEISURE WANDER OVER AND PARTAKE? THERE THEY ARE.

AT YOUR LEISURE.

MR. SWEEDLER: THANK YOU, MR. CHAIRMAN,

MEMBERS OF THE BOARD. IT'S A PLEASURE TO SPEAK WITH

YOU THIS AFTERNOON. FIRST, LET ME BE CLEAR I'M NOT

GOING TO BE ASKING FOR ANY MONEY. TO THE CONTRARY,

THIS IS A PROGRAM THAT BRINGS IN MONEY. AND I'D

LIKE TO QUOTE SOMEBODY VERY WISE, DR. STEWARD, FROM

ABOUT FIVE MINUTES AGO. CALIFORNIA IS NOT THE

WORLD, AND THERE'S A LOT OF TALENT OUT THERE. AND

THAT'S CLEARLY A VERY TRUE STATEMENT, AND IT'S ONE

OF THE MAIN REASONS THAT WE HAVE THIS PROGRAM.

IT'S AN ACTIVE PROGRAM, AND IT'S BEEN

QUITE SOME TIME SINCE WE'VE COME TO THE BOARD TO

TELL YOU ABOUT IT, WHAT IT'S DOING, AND HOW IT'S

DOING. SO OUR CHAIRMAN ASKED ME TO COME AND MAKE

THIS PRESENTATION TODAY.

AS YOU KNOW, WE FUND RESEARCH IN

CALIFORNIA. THERE'S A LOT OF GREAT RESEARCH GOING

ON ELSEWHERE. SOMETIMES WE BRING THOSE PEOPLE TO

CALIFORNIA, BUT IT'S IMPORTANT FOR RESEARCHERS IN

CALIFORNIA TO BE ABLE TO WORK WITH THE BEST PEOPLE

IN THE FIELD. SOMETIMES WHAT THEY NEED IS TO WORK

WITH SOMEBODY WHO IS THE BEST AT ONE VERY SPECIFIC

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TECHNOLOGY THAT'S REALLY THE PIECE THAT'S MISSING TO

MAKE THEIR PROJECT MOVE FORWARD.

AND THIS IS A VERY SCIENTIST DRIVEN

PROGRAM. SCIENTISTS TELL US THAT -- CALIFORNIA

SCIENTISTS TELL US THAT THERE ARE PEOPLE OUT THERE

WHO THEY WANT TO BE ABLE TO WORK WITH IN DIFFERENT

PLACES. SO THIS IS A PROGRAM THAT ALLOWS

CIRM-FUNDED PROJECTS IN CALIFORNIA TO ACCESS

RESOURCES AND EXPERTISE BEYOND WHAT CIRM PROVIDES.

I THINK THEY USED TO SAY IN THE BRITISH

EMPIRE THAT THE SUN NEVER SETS ON IT, AND THAT'S

MORE OR LESS TRUE OF OUR COLLABORATIVE FUNDING

NETWORK. SO AS YOU CAN SEE FROM THIS MAP, WE COVER

ALMOST EVERY CONTINENT AND MOST OF THE COUNTRIES

THAT ARE PRODUCING SIGNIFICANT RESEARCH IN THIS AREA

WITH SOME GAPS. MOST OF OUR COLLABORATIVE FUNDING

PARTNERS ARE NATIONAL LEVEL RESEARCH FUNDING

AGENCIES. SOME OF THEM ARE LIKE CALIFORNIA,

SUBNATIONAL STATE, PROVINCIAL LEVEL.

WE ALSO HAVE COLLABORATIVE FUNDING

RELATIONSHIPS WITH SOME DISEASE FOUNDATIONS, AND I

WILL TALK TO YOU ABOUT HOW ALL OF THOSE DIFFERENT

KINDS OF RELATIONSHIPS WORK.

OVERALL THE WAY WE WORK WITH OUR PARTNERS

IS THROUGH -- FIRST OF ALL, WE OFFER JOINT FUNDING

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OPPORTUNITIES. AND I'LL GO INTO MORE DETAILS ABOUT

ALL OF THESE. BUT THIS IS ANNOUNCING AN OPPORTUNITY

FOR A COLLABORATIVE PROJECT, A COLLABORATIVE

PROPOSAL, TO COME TO US. WE WORK WITH OUR PARTNERS

TO SUPPORT COLLABORATIONS WHERE AN EXISTING

CIRM-FUNDED PROJECT CAN BENEFIT FROM A COLLABORATIVE

ELEMENT TO BE ADDED AND SUPPORTED BY AN EXTERNAL

RESEARCH AGENCY.

WE WORK WITH OUR COLLABORATIVE FUNDING

PARTNERS IN WAYS THAT ARE NOT DIRECTLY FUNDING

RELATED. THESE ARE MANY OF THE PREMIERE STEM CELL

RESEARCH AGENCIES AROUND THE WORLD, AND IT IS AN

EXCELLENT WAY TO WORK WITH THEM ON UNDERSTANDING THE

SCIENTIFIC LANDSCAPE, SCIENTIFIC PRIORITIES.

AND THAT TRANSITIONS INTO THE NEXT --

SOME OF THE OTHER ITEMS THERE, SHARED EXPERTISE, THE

REGULATORY ISSUES THAT WILL ARISE IF THERAPIES

DEVELOPED IN ONE COUNTRY ARE TO BE AVAILABLE IN

ANOTHER COUNTRY.

AND WE ALSO WORK WITH OUR COLLABORATIVE

FUNDING PARTNERS AT TIMES TO SPONSOR JOINT

SCIENTIFIC WORKSHOPS WHICH ARE OFTEN THE WORKSHOPS

THAT BOTH LEAD TO NEW COLLABORATIVE IDEAS,

INTERNATIONAL COLLABORATIONS, AND SOMETIMES THEY'VE

LED TO SOME EXCELLENT COLLABORATIONS BETWEEN

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CALIFORNIA SCIENTISTS WHO HAPPEN TO BE AT THESE

WORKSHOPS.

SO THE PRIMARY WAY THAT WE BRING THIS

FUNDING IN IS BY HAVING COLLABORATIVE FUNDING

PARTNERS JOIN US IN A PARTICULAR RFA. SO WE HAVE

OUR STANDARD RFA PROCESS, AND EACH FUNDING PARTNER

DECIDES, BASED ON THE INFORMATION WE PROVIDE AND

THEIR PRIORITIES, WHETHER THEY WANT TO JOIN A

PARTICULAR RFA.

ONCE WE'VE MADE THAT OPPORTUNITY AVAILABLE

AND WE PUT THAT IN THE RFA AND THE FUNDING PARTNER

AGENCY EXPLAINS HOW THEIR HALF OF THE PROCESS WILL

WORK, AND WE DO EVERYTHING WE CAN TO STREAMLINE THIS

SO THAT THERE ISN'T A DUPLICATION OF EFFORT BY

APPLICANTS, WHERE THERE'S A TEAM OUT THERE THAT HAS

A COLLABORATIVE PROPOSAL, THEY PREPARE THE CIRM

APPLICATION, WHICH IS SET UP TO ALLOW THOSE

COLLABORATIVE POSSIBILITIES TO BE IDENTIFIED, THEY

HAVE THEIR FUNDING AND TASKS LAID OUT FOR BOTH THE

CALIFORNIA TEAM AND THE EXTERNAL TEAM.

THE ENTIRE PROPOSAL IS REVIEWED AS A

SCIENTIFICALLY UNIFIED PROJECT BY THE GRANTS WORKING

GROUP. AND IF ULTIMATELY BOTH CIRM AND ITS FUNDING

PARTNER APPROVE FUNDING FOR A PROJECT, THEN WE FUND

THE PART IN CALIFORNIA. THEY FUND THE PART IN THEIR

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JURISDICTION. WE COORDINATE ON ISSUING THE AWARDS

SO THAT THEY START AT THE SAME TIME. EVERYONE CAN

BE MOVING FORWARD TOGETHER. WE COOPERATE ON

OVERSIGHT OF THESE AWARDS. WE TRY AS MUCH AS

POSSIBLE TO ALLOW THE TEAMS TO DO A SINGLE PROGRESS

REPORT THAT WORKS FOR BOTH AGENCIES. WE SEE WHAT'S

GOING ON WITH THE WHOLE PROJECT. DEPENDING ON THE

PARTNER, WE'LL OFTEN GET ON THE PHONE WITH OUR

OPPOSITE NUMBERS AT THOSE AGENCIES TO CHECK IN AND

SEE WHAT EACH OF US THINKS ABOUT HOW A PROJECT IS

GOING OR IF WE HAVE CONCERNS.

AT THE DISEASE TEAM STAGE, WHERE WE HAVE

THESE VERY INFORMATIVE CLINICAL DEVELOPMENT ADVISORY

PANEL MEETINGS, OUR COLLABORATIVE FUNDING PARTNERS

LOVE THOSE. THEY WILL COME INTO THE COUNTRY TO

ATTEND THOSE OR THEY WILL PARTICIPATE BY PHONE

BECAUSE IT IS A LEVEL OF OVERSIGHT AND INPUT THAT IT

IS HARD FOR OTHER AGENCIES TO MATCH.

THE OTHER WAY THAT THESE COLLABORATIVELY

FUNDED PROJECTS COME TOGETHER IS WHAT WE CALL A

BOLT-ON, AND THAT'S WHEN CIRM HAS APPROVED AND

INITIATED A NEW CALIFORNIA ONLY PROJECT AND A

SCIENTIST FROM OUTSIDE OF CALIFORNIA IN ONE OF OUR

FUNDING AREAS CONTACTS THE CALIFORNIA SCIENTIST AND

SAYS I WOULD LIKE TO WORK WITH YOU. I HAVE A

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PROPOSAL THAT COULD ADD VALUE TO WHAT YOU'RE DOING.

AND THEY WILL GO TO THEIR FUNDING AGENCY. AND IF

THEIR FUNDING AGENCY IS WILLING TO MAKE THE FUNDING

AVAILABLE, AND WE AGREE THAT IT SUPPORTS THE GOALS

OF THE CIRM-FUNDED PROJECT, THEN WE WILL SUPPORT

THAT.

SO WHAT THAT MEANS, THEN, IS NEW FUNDING

AND NEW RESOURCES ARE BEING BROUGHT TO A PROJECT

THAT CIRM HAS ALREADY DECIDED TO GO AHEAD WITH.

WE ALSO WORK WITH A GROWING NUMBER OF

DISEASE FOUNDATIONS. AND UNLIKE THESE FUNDING

AGENCIES, THESE ARE NOT NECESSARILY GEOGRAPHICALLY

BASED. AND THEY'RE ABLE TO PROVIDE FUNDING DIRECTLY

TO THE VERY SAME RESEARCHERS THAT WE'RE SUPPORTING.

SO IT'S AN OPPORTUNITY TO GET ADDITIONAL DOLLARS AND

ADDITIONAL RESOURCES OF OTHER KINDS MADE AVAILABLE

TO THE RESEARCH TEAMS THAT ARE WORKING ON

CIRM-FUNDED AWARDS.

WHEN ALAN MENTIONED EARLIER SOME OF THE

LEVERAGED FUNDING THAT WE BROUGHT IN LAST YEAR, PART

OF THAT WAS A $3 MILLION GRANT FROM THE JUVENILE

DIABETES RESEARCH FOUNDATION THAT WAS PROVIDING

MATCHING FUNDS ALONG WITH OUR GRANT TO VIACYTE

THROUGH THE STRATEGIC PARTNERSHIP PROGRAM.

ONE ADVANTAGE THAT WE CAN OFFER TO THESE

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DISEASE FOUNDATIONS IS THAT WE HAVE A LEVEL OF

INTENSIVE SCIENTIFIC REVIEW AT THE FRONT END THAT IS

HARD FOR MOST ORGANIZATIONS TO MATCH. WE HAVE AN

AMAZING GRANTS WORKING GROUP, AND OUR SCIENCE OFFICE

PULLS TOGETHER THE TOP PEOPLE FROM THAT GROUP AND

OTHERS TO REVIEW THESE PROPOSALS. SO A DISEASE

FOUNDATION HAS THE CONFIDENCE OF KNOWING THAT THIS

HAS BEEN VERY WELL VETTED, AND THEY KNOW THAT IT

WILL CONTINUE TO BE CAREFULLY MONITORED. SO FOR

THOSE ORGANIZATIONS, WHICH LIKE EVERYONE HAVE

LIMITED DOLLARS TO SPREAD AROUND, WE'RE PROVIDING

SOME VALUE ADDED FOR THEM ON THIS WHEN THEY CAN PUT

IN FUNDS THAT EXPAND OUR PROJECTS.

AND THEN WE HAVE A UNIQUE RELATIONSHIP

WITH THE NATIONAL INSTITUTES OF HEALTH. PART OF IT

WORKS SIMILARLY TO OUR COLLABORATIVE FUNDING

PROGRAMS. AND THAT IS WE WILL RECEIVE PROPOSALS IN

WHICH THERE IS A CALIFORNIA PI AND AN EXTERNAL PI.

AND IN THIS CASE THAT EXTERNAL PI IS AN INTRAMURAL

RESEARCHER AT NIH. SO THIS IS NOT NIH GRANT FUNDING

TO THEIR FUNDED EXTERNAL RESEARCHERS. THESE ARE THE

PEOPLE WORKING ON THAT CAMPUS IN BETHESDA. AND WHEN

THESE PROPOSALS ARE REVIEWED AND APPROVED, THE

SCIENTIFIC MERIT IS THERE, THEN NIH USES INTERNAL

NIH FUNDING AND CHANNELS A BUDGET SPECIFICALLY FOR

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THAT PROJECT.

THE OTHER ADVANTAGE THAT WE GET THROUGH

THIS COLLABORATIVE FUNDING RELATIONSHIP IS THAT

CIRM-FUNDED RESEARCHERS, WHETHER OR NOT THEY'RE

WORKING WITH AN NIH INTRAMURAL RESEARCHER, CAN GET

ACCESS TO SPECIALIZED RESOURCES THAT ARE NORMALLY

ONLY AVAILABLE TO NIH RESEARCHERS OR NIH-FUNDED

RESEARCHERS. AND THAT CAN RANGE FROM INFORMATIONAL

RESOURCES, CELL LINES, TRAINING AND SPECIALIZED

KINDS OF RESOURCES AVAILABLE AT THE NIH CLINICAL

CENTER. AND THESE CAN COME IN AT ANY STAGE OF A

PROJECT. THEY CAN BE PART OF THE APPLICATION. THEY

CAN COME IN LATER ON IN A PROJECT THAT'S ALREADY

UNDER WAY. IT'S A VERY FLEXIBLE RELATIONSHIP THAT

IS INTENDED TO RESPOND TO THE NEEDS OF EACH OF OUR

RESEARCH PROJECTS.

SO I MENTIONED THAT PARTNERS PARTICIPATE

ONE RFA AT A TIME. SO WHAT I'VE PUT UP ON THIS

CHART IS A LIST OF OUR DIFFERENT FUNDING PROGRAMS

AND A LIST OF WHICH FUNDING PARTNERS HAVE MADE

FUNDING AVAILABLE FOR EACH OF THOSE PROGRAMS. AND

AS YOU CAN SEE, THERE'S BEEN SUBSTANTIAL

PARTICIPATION. AND THAT PARTICIPATION HAS RUN THE

FULL RANGE OF THE TYPE OF RESEARCH THAT WE SUPPORT.

NUMEROUS COUNTRIES INVOLVED IN BASIC BIOLOGY,

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TRANSLATIONAL, AND THE IND ENABLING AND CLINICAL

RESEARCH, AS WELL AS SOME OF THE MORE SPECIALIZED

RFA'S WE'VE OFFERED, TOOLS AND TECHNOLOGIES,

TRANSPLANTATION IMMUNOLOGY. SO THE INTEREST IS

BROAD.

AND THEN THIS CHART SHOWS ACTUAL

COLLABORATIVE FUNDING AWARDS THAT HAVE BEEN MADE IN

EACH OF OUR RESEARCH PROGRAMS. AND AGAIN, IT'S

DISTRIBUTED ACROSS THE CONTINUUM OF THE TYPES OF

RESEARCH THAT WE FUND WITH THE LARGEST AMOUNTS IN

OUR BIGGEST PROGRAMS, EARLY TRANSLATIONAL AND

DISEASE TEAM, AT LEAST BIGGEST PROGRAMS IN TERMS OF

AWARD SIZE.

AND THEN FINALLY, IN TERMS OF THIS

SCORECARD PART OF IT, I JUST WANTED TO HIGHLIGHT FOR

YOU JUST IN THE LAST YEAR THESE ARE COLLABORATIVE

PROGRAM -- COLLABORATIONS THAT HAVE COME INTO BEING

AND FUNDED THROUGH OUR VARIOUS PROGRAMS. SO THE

PROVINCE OF ANDALUCIA HAS JOINED ONE OF OUR DISEASE

TEAMS. AUSTRALIA HAS JOINED AN EARLY TRANSLATIONAL

PROGRAM. OUR FIRST COLLABORATION WITH FRANCE IS A

BASIC BIOLOGY PROGRAM. GERMANY, EARLY

TRANSLATIONAL. OUR FIRST COLLABORATION WITH INDIA,

BASIC BIOLOGY. ONE OF MANY -- ONE OF SEVERAL

COLLABORATIONS WITH THE MARYLAND STEM CELL RESEARCH

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PROGRAM IS A BASIC BIOLOGY PROGRAM. AND WE HAVE TWO

INVOLVING NIH, A DISEASE TEAM PROGRAM AND A

SPECIALIZED IPSC CONSORTIUM THAT WE JOINED.

AND WHEN YOU ADD IT ALL UP, WE HAVE 30

CIRM PROJECTS THAT HAVE COLLABORATIVE FUNDING

PARTICIPATION, AND THE FUNDING PARTNERS HAVE

COMMITTED OVER $70 MILLION TO THOSE PROJECTS. SO

THAT IS ALL LEVERAGE THAT'S COMING IN TO EXTEND THE

IMPACT OF THE CIRM FUNDING FOR THOSE AWARDS.

SO I'M HAPPY TO ANSWER ANY QUESTIONS THAT

YOU HAVE.

CHAIRMAN THOMAS: DR. BERGLUND.

DR. BERGLUND: THANK YOU. I THINK THIS

SHOWS THAT THIS CAN BE A VERY POWERFUL PROGRAM GOING

FORWARD. I HAVE TO ASK TWO THINGS. I WAS WONDERING

WHAT'S THE RATIO SORT OF BETWEEN CIRM FUNDING AND

EXTERNAL FUNDING ON AVERAGE?

MR. SWEEDLER: YES. IT'S A WIDE RANGE IN

PART BECAUSE FUNDERS HAVE DIFFERENT AMOUNTS

AVAILABLE, RESEARCH COSTS ARE A DIFFERENT AMOUNT IN

DIFFERENT COUNTRIES. THE HIGHEST PARITY IS WITH THE

CANCER STEM CELL CONSORTIUM OF CANADA WHO CO-FUNDS

TWO OF OUR DISEASE TEAM I PROJECTS WITH US. AND

THERE IT'S ONE TO ONE DEPENDING ON THE EXCHANGE

RATE, BUT IT'S 20 MILLION U.S. AND 20 MILLION

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CANADIAN TO EACH OF THOSE PROJECTS. MOST OF THE

OTHERS IT'S A LESSER LEVEL OF COMMITMENT, USUALLY

AROUND A THIRD OR SO. BUT IT REALLY DEPENDS ON THE

TYPE OF PROJECT. AND WHAT I'VE HEARD FROM THE

FUNDING PARTNERS IS THAT THEIR PERCEPTION IS THAT

THE RELATIVE FUNDING AMOUNT HAS AN IMPACT ON HOW THE

PARTNERSHIPS OPERATE.

DR. TROUNSON: A LOT OF THESE PLACES DON'T

HAVE INDIRECTS EITHER, SO THEY DON'T PAY ANY

INDIRECT.

DR. BERGLUND: AND THE SECOND QUESTION, I

WONDER HAS THIS ACTUALLY COME UP IN THE QUESTION

WITH REGARDS TO TRAINING GRANTS? I THINK THIS COULD

ACTUALLY BE A VERY INTERESTING OPPORTUNITY TO BRING

TRAINEES TOGETHER FROM DIFFERENT CULTURES, DIFFERENT

NATIONS, AND ACTUALLY DO OPEN THE EYES OF THOSE

TRAINEES FOR OPPORTUNITIES IN CALIFORNIA OVER TIME.

MR. SWEEDLER: YOU KNOW, WE'VE LOOKED INTO

THE POSSIBILITY OF SORT OF SCHOLAR EXCHANGE

PROGRAMS. MY SENSE IS THAT, FIRST OF ALL, A LOT OF

THAT IS HAPPENING ALREADY, AND IT WAS A PRETTY

TRANSACTIONALLY LABOR INTENSIVE KIND OF THING TO SET

UP. BY THE TIME I WAS INTO THE FOURTH PAGE ON THE

STATE DEPARTMENT WEB SITE ABOUT THE VISA

REQUIREMENTS, I STARTED THINKING THIS MAY NOT BE

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WHAT OUR FIRST PRIORITY SHOULD BE.

DR. YAFFE: I JUST WANTED TO ADD THAT OUR

TRAINING GRANTS HAVE NO RESTRICTION WITH REGARD TO

CITIZENSHIP OR GREEN CARD STATUS. SO UNLIKE THE NIH

TRAINING GRANTS, WE CAN SUPPORT STUDENTS, POST DOCS,

AND CLINICAL FELLOWS FROM OTHER COUNTRIES.

DR. BERGLUND: I APPRECIATE THAT. WE HAVE

HAD AND I'M SURE OTHER UNIVERSITIES HAVE HAD PRETTY

GOOD EXPERIENCE OF ACTUALLY HAVING THE TRAINEES BE

THE GLUE BETWEEN MENTORS IN ONE ORGANIZATION AND

MENTORS IN ANOTHER. THE MENTORS MAY NOT NECESSARILY

COMMUNICATE THAT MUCH, BUT THE STUDENTS BRING THEM

TOGETHER.

MR. SWEEDLER: AND THIS IS -- IT'S

CERTAINLY AN AVAILABLE ELEMENT WITHIN THESE AWARDS.

CIRM AWARDS PROVIDE SUBSTANTIAL TRAVEL FUNDING WHEN

THAT'S AN APPROPRIATE COMPONENT. AND I'M NOT A

SCIENTIST, BUT IT'S MY UNDERSTANDING THAT THIS KIND

OF LABORATORY EXCHANGE IS A PRETTY COMMON FORM OF

CROSS TRAINING AND TRANSFER OF TECHNOLOGY.

I ALSO DID WANT TO MENTION SOMETHING THAT

WE'RE PRETTY EXCITED ABOUT. THIS IS A NEW RFA

THAT'S BEING ISSUED TODAY. THIS IS A CONCEPT THAT

THE BOARD APPROVED LAST YEAR. IT WAS RECOMMENDED BY

OUR EXTERNAL ADVISORY PANEL. AND THIS IS KIND OF

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THE FLIP SIDES OF THOSE BOLT-ONS THAT WE TALKED

ABOUT.

THIS IS A PROGRAM, OUR EXTERNAL INNOVATION

PROGRAM, WHERE CALIFORNIA RESEARCHERS CAN COME TO US

AND SAY I WOULD LIKE CIRM FUNDING FOR A NEW

CALIFORNIA PROJECT THAT'S INTENDED TO COLLABORATE

WITH AN EXISTING PROJECT OUTSIDE OF CALIFORNIA. AND

THERE IS GREAT WORK GOING ON OUTSIDE OF CALIFORNIA.

IN SOME CIRCUMSTANCES THERE IS UNIQUE BARRIER

BREAKING WORK GOING ON OUTSIDE OF CALIFORNIA, AND

IT'S IMPORTANT FOR THE CALIFORNIA RESEARCH COMMUNITY

TO HAVE ACCESS TO THAT.

SO THESE AWARDS ALLOW CALIFORNIA

INVESTIGATORS TO PROPOSE THESE PROJECTS. AND IT

FILLS IN SOME GAPS IN OUR EXISTING PROGRAMS. THAT

MAP THAT I SHOWED YOU HAD A LOT OF COUNTRIES ON IT,

BUT PEOPLE WHO KNOW THE FIELD SAW A NUMBER OF

ABSENCES AS WELL. THERE ARE COUNTRIES WHERE, FOR A

VARIETY OF REASONS, WE'VE JUST NOT BEEN ABLE TO

ESTABLISH A COLLABORATIVE FUNDING RELATIONSHIP. SO

THIS WOULD ALLOW CALIFORNIA RESEARCHERS TO

COLLABORATE WITH INVESTIGATORS IN COUNTRIES WHERE WE

DO NOT HAVE THOSE COLLABORATIVE FUNDING PARTNERSHIP

ARRANGEMENTS IN PLACE.

MS. WINOKUR: WHEN YOU LIST THE COUNTRIES

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WITH WHOM WE HAVE ARRANGEMENTS, WHAT IS THE

ORGANIZATION OR STRUCTURE WITHIN THOSE COUNTRIES?

MR. SWEEDLER: SURE. I'LL GIVE YOU A FEW

EXAMPLES. IN THE UNITED KINGDOM IT'S THE MEDICAL

RESEARCH COUNCIL WHICH IS THE PRIMARY LIFE SCIENCES

RESEARCH GRANTING AGENCY THERE. SIMILAR WITH THE

NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL IN

AUSTRALIA. IN CANADA IT'S THE CANCER STEM CELL

CONSORTIUM, SO IT IS A CONSORTIUM THAT'S FOCUSED ON

ONE PARTICULAR DISEASE RESEARCH AREA. ANDALUCIA,

IT'S FOCUSED MORE AT THE TRANSLATIONAL CLINICAL END

OF THINGS. IN GERMANY IT'S THEIR PRIMARY RESEARCH

FUNDING AGENCY, THE BMBF. AND PLEASE DON'T ASK ME

TO PRONOUNCE --

MS. WINOKUR: WHAT IS OUR STATE LIKE

MARYLAND?

MR. SWEEDLER: SO MARYLAND HAS A STEM CELL

RESEARCH FUNDING INITIATIVE THAT IS SIMILAR TO CIRM

IN ITS AIMS, BUT MUCH SMALLER. SO WE'VE WORKED OUT

A PROGRAM WITH THEM. THEY'RE NOT ABLE TO JOIN OUR

RFA'S FOR TECHNICAL REASONS. SO WHEN THEY DO THEIR

FUNDING ROUND EACH YEAR, THEIR RESEARCHERS ARE GIVEN

A LIST OF NEW CIRM AWARDS. AND THEY HAVE A SPECIAL

APPLICATION TRACK FOR THOSE WHO ARE PROPOSING TO

COLLABORATE WITH CALIFORNIA RESEARCHERS.

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CHAIRMAN THOMAS: IAN, I GOT A QUESTION OR

MAYBE BETTER DIRECTED TO ALAN. ARE THERE ANY OTHER

POTENTIAL PARTNERS IN THE OFFING OUT THERE, AND HOW

ARE WE DOING IN LANDING THEM?

DR. TROUNSON: YEAH. WE'RE IN DISCUSSIONS

WITH THE SPACE AGENCY AND CHILE. IN CHILE THEY

FORMED A FUND THAT WAS SIMILAR TO THE CANADIAN

GENOMICS FUND. SO IT'S PROPOSED THAT I TALK TO

CHILE ABOUT DOING SOMETHING TOGETHER. BUT I

THINK --

CHAIRMAN THOMAS: I TRUST YOU WILL RUG UP

WHEN YOU GO DOWN THERE.

DR. TROUNSON: BUT I ALSO THINK PROBABLY

SOME OF THE OTHER DISEASE FOUNDATIONS ARE PROBABLY

IMPORTANT AS WE MOVE INTO THE CLINICAL PROGRAMS.

THE HIV ASSOCIATION JUST -- WE JUST JOINED UP WITH

THE HIV ASSOCIATION.

MR. SWEEDLER: THE AIDS HEALTHCARE

FOUNDATION.

DR. TROUNSON: RIGHT. AND SO I THINK

THERE ARE A NUMBER OF THOSE OTHERS THAT WE CAN SORT

OF LINK WITH IN THE SPECIAL PROGRAMS. AND SO WE

CONTINUE TO KEEP OURSELVES BRIEFED AND TALKING TO

THOSE PEOPLE. SO THEY'RE THERE. AND WE'LL BRING

THOSE OPPORTUNITIES FORWARD, I THINK, IN DUE COURSE

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WHEN IT LOOKS LIKE THEY MIGHT WORK.

MR. SWEEDLER: THOSE ARE BOTH EXAMPLES OF

SITUATIONS WHERE LEADING CALIFORNIA RESEARCHERS CAME

TO US AND SAID THERE'S SOMEONE I WANT TO WORK WITH

HERE, AND CAN YOU GET A COLLABORATIVE RELATIONSHIP

IN PLACE SO WE CAN MAKE THAT WORK.

CHAIRMAN THOMAS: OTHER COMMENTS? OKAY.

THANK YOU, IAN.

WE WILL NOW PROCEED TO AN UPDATE REGARDING

THE IMPLEMENTATION OF THE PERFORMANCE AUDIT

RECOMMENDATIONS. HEAR FROM ALEX.

MS. CAMPE: CHAIRMAN THOMAS AND MEMBERS OF

THE BOARD AND MEMBERS OF THE PUBLIC, THANK YOU FOR

LETTING ME SHARE WITH YOU SOME UPDATES ON THE

PERFORMANCE AUDIT. FIRST, AS REQUIRED BY LAW, CIRM

DID COMMISSION A PERFORMANCE AUDIT OF CIRM'S

OPERATIONS. THE AUDITORS FROM THE ACCOUNTING FIRM

OF MOSS ADAMS COMPLETED THE AUDIT AND RELEASED THE

REPORT AND PRESENTED TO THE ICOC IN MAY OF 2012.

CIRM WAS FOUND TO BE IN FULL COMPLIANCE WITH ALL

APPLICABLE LAWS AND POLICIES.

MOSS ADAMS MADE 24 RECOMMENDATIONS FOR

IMPROVING OUR PERFORMANCE, AND OUR GOAL WAS TO

COMPLETE THEM BY JUNE 30TH OF THIS YEAR. I HAVE

PROVIDED UPDATES ON OUR PROGRESS TO THIS BOARD LAST

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DECEMBER AND THE CITIZENS FINANCIAL ACCOUNTABILITY

OVERSIGHT COMMITTEE IN FEBRUARY OF THIS YEAR.

THE STAFF AT CIRM HAS WORKED EXTREMELY

HARD TO ACCOMPLISH AND FULFILL THESE RECOMMENDATIONS

FOR IMPROVED PERFORMANCE. I WOULD LIKE TO UPDATE

YOU ON OUR ACHIEVEMENTS ON THE RECOMMENDATIONS TO

DATE.

THE PRESENTATION MATERIALS YOU HAVE IN

YOUR BINDER ARE ACTUALLY MORE COMPREHENSIVE THAN

WHAT YOU WILL SEE ON THE SCREEN. I'M GOING TO FOCUS

ON TIER I, WHICH WERE THE TOP PROPERTIES THAT MOSS

ADAMS HAD PROVIDED US, AND THEY WERE ALL COMPLETED.

SO LET ME RUN THROUGH THE TIER I

RECOMMENDATIONS. ALL 12 HAVE BEEN COMPLETED. THE

FIRST ONE WAS THE GRANTS MANAGEMENT SYSTEM. IP

MODULE WAS RELEASED. THE IP MODULE ALSO INCLUDED

COMMERCIALIZATION ACTIVITY QUESTIONS. WE DEVELOPED

A COMMUNICATIONS STRATEGY. THERE WAS A MANDATORY

GRANT OUTCOME CLOSEOUT SURVEY THAT WAS ADDED AS WELL

TO OUR GRANTS MANAGEMENT SYSTEM. THE FIFTH HERE IS

WE INCORPORATED MILESTONES INTO OUR PROJECT

MANAGEMENT SOFTWARE, WHICH IS CONNECTED TO OUR

GRANTS MANAGEMENT SYSTEM. OUR BOND FORECASTING

PROCEDURES WERE IMPLEMENTED. OUR DIGITAL DASHBOARD

IS NOW IN USE WITH SENIOR STAFF. WE NOW HAVE A

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CENTRAL LOCATION FOR PROCUREMENT DOCUMENTATION. AND

WE ARE MONITORING THE 6-PERCENT ADMINISTRATIVE CAP

WITH THE USE OF MODELING AND EVALUATION OF STAFFING

AND RESOURCE NEEDS.

THE LAST ONES IN THE TIER I WERE WE

ACCELERATED OUR PROGRESS REPORT REVIEWS WITH ONLINE

ACCESS. WE HAVE PURCHASED AND ARE ROLLING OUT OUR

DOCUMENT MANAGEMENT SYSTEM. AND FINALLY, WE HAVE

COMPLETED AN HR FORECASTING MODEL, AND WE HAVE FOUR

STAFF TRAINED ON THAT. THOSE ARE ALL THE TIER I'S.

THE TIER II'S, SIX OF EIGHT HAVE BEEN

COMPLETED, AND I'LL RUN THROUGH THOSE. THE OFFICE

OF THE CHAIR, OFFICE OF THE PRESIDENT COOPERATION

HAS BEEN ENHANCED TREMENDOUSLY. WE HAVE STREAMLINED

OUR STANDING MEETINGS WITHIN THE OFFICE. THE STATE

CONTROLLERS, WE NOW HAVE ACCESS TO THEIR SYSTEM.

ELONA CAME TO YOU IN DECEMBER WITH A BUSINESS

DEVELOPMENT PLAN. WE HAVE A WEB SITE PLAN THAT'S IN

PLACE, AND WE HAVE A BRAND-NEW WEB SITE THAT'S BEEN

ROLLED OUT. AND THERE'S BEEN MANY THINGS IN THE

SCIENCE OFFICE THAT HAVE BEEN PRIORITIZED TO

STREAMLINE THE VARIOUS WORK THAT THEY DO.

THERE ARE TWO THAT ARE STILL IN PROCESS

THAT ARE TIER II ITEMS. ONE IS THE FINANCE WORKFLOW

DATABASE THAT CHILA MENTIONED EARLIER. THAT'S GOING

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TO BE ROLLED OUT THIS MONTH. AND THEN AN I.T. PLAN

WAS RECOMMENDED, AND WE HAVE THAT DRAFT WITH OUR

VENDOR CURRENTLY FOR INPUT.

FINALLY, THERE WERE FOUR TIER III

RECOMMENDATIONS. THEY'VE ALL BEEN COMPLETED. FIRST

WAS A FORMAL ON-BOARDING PROGRAM FOR NEW EMPLOYEES

TO ENSURE THAT THEY WERE INTEGRATED INTO THE

ORGANIZATION AS EFFICIENTLY AS POSSIBLE AND AS

EFFECTIVELY AS POSSIBLE.

SECOND, THE ICO BOARD CODE OF CONDUCT WAS

COMPLETED, AND YOU ALL RECEIVED A COPY OF THAT

MEETINGS AGO. WE EVALUATED THE CONFLICT OF

INTEREST, CHECKED REDUNDANCIES; AND, FINALLY, WE DID

ADDRESS THE RECRUITMENT AND RETENTION TRANSITION

PLAN AND WILL CONTINUE TO REVIEW THAT.

SO THAT ACTUALLY ENDS MY PRESENTATION ON

THE UPDATES ON THE PERFORMANCE REVIEW. DOES ANYBODY

HAVE ANY QUESTIONS?

CHAIRMAN THOMAS: OKAY. THANK YOU. VERY

GOOD JOB, ALEX AND ALL WHO WERE INVOLVED IN THE

IMPLEMENTATION PHASE. GOOD TO BE DOWN TO THE VERY

END OF THE HOME STRETCH HERE. SENATOR TORRES.

MR. TORRES: ALEX, WE'RE GOING TO SEND

THAT UPDATE TO THE LEGISLATURE, CORRECT?

MS. CAMPE: I WILL WORK WITH YOU TO DO

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WHATEVER YOU'D LIKE US TO DO, YES.

MR. TORRES: WE SHOULD DO THAT. NOT EVERY

MEMBER, BUT CERTAIN MEMBERS.

CHAIRMAN THOMAS: OKAY. LAST, BUT NOT

LEAST, KEVIN IS GOING TO PRESENT US WITH THE

COMMUNICATIONS UPDATE.

MR. MC CORMACK: CHAIR THOMAS, MEMBERS OF

THE BOARD, AND MEMBERS OF THE PUBLIC, IT'S ALWAYS

LOVELY TO HAVE A CHANCE TO COME AND TALK TO YOU AND

GIVE YOU AN UPDATE ON WHAT WE'VE BEEN UP TO. AND

IT'S BEEN A PRETTY BUSY SUMMER SO FAR. I THINK YOU

ALL SAW AS YOU CAME IN THE NEW "STORIES OF HOPE."

THIS IS THE -- WHAT WE DID LAST YEAR WHEN WE HAD THE

NEW KIND OF ANNUAL REPORT, WE COMBINED THE DETAILS

REQUIRED IN THE ANNUAL REPORT BY PROP 71 AND SOME

STORIES ABOUT PATIENTS. AND WE DECIDED THIS YEAR TO

BREAK THEM OUT BECAUSE THE STORIES OF HOPE ARE WHAT

THE PUBLIC ARE REALLY INTERESTED IN. AND SO THIS

GIVES US A REALLY POWERFUL COMMUNICATIONS TOOL WHEN

WE GO AROUND TO HEALTH FAIRS AND OTHER EVENTS TO

SHARE THIS WITH THE PUBLIC. THEY'RE REALLY

INTERESTED IN STORIES LIKE THIS. WE'RE GOING TO

CONTINUE WITH THIS MODEL FOR A WHILE.

AND WHAT'S NICE ABOUT THIS IS THAT WE CAN

PRODUCE SEVERAL VERSIONS OF THIS THROUGHOUT THE YEAR

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SO IT'S NOT JUST ONE STATIC DOCUMENT. IN FACT, OUR

NEXT VERSION WILL TRANSLATE INTO SPANISH AND ALSO

INCLUDE STORIES THAT ARE ABOUT DISEASES AND

CONDITIONS OF PARTICULAR INTEREST TO THE LATINO

COMMUNITY. SO WE'RE GOING TO BE WORKING WITH

SENATOR TORRES TO KIND OF IDENTIFY INDIVIDUALS,

IDENTIFY STORIES THAT WE THINK WILL RESONATE THERE.

MR. TORRES: HAVING BEEN A LATINO MOST OF

MY LIFE.

DR. MC CORMACK: YESTERDAY WE GOT A REALLY

GOOD ARTICLE IN THE LOS ANGELES TIMES, WHICH IS A

PREVIEW OF THE VOTE THAT YOU TOOK HERE TODAY ON THE

ALPHA STEM CELLS CLINIC. AND DRS. MILLAN AND DEWITT

DID A GREAT JOB OF EXPLAINING EXACTLY WHAT IT IS,

WHY WE'RE DOING THAT, WHAT OUR HOPES AND DREAMS ARE.

AND SO I THINK THAT'S THE KIND OF ARTICLE WE WANT TO

SEE MORE OF BECAUSE IT REALLY LOOKS AT THE WORK THAT

WE DO AND THE POWER THAT IT HAS. SO THAT WAS REALLY

GOOD.

YESTERDAY WE ALSO FOUND OUT THAT WE CAME

THIS CLOSE TO WINNING THE BEST PR EVENT IN A

NATIONAL PR COMPETITION FOR OUR ELEVATOR PITCH

CHALLENGE. WE LOST TO THE GIRL SCOUTS. THIN MINTS,

YOU JUST CAN'T COMPETE WITH THAT STUFF.

SO AS MENTIONED EARLIER, ON JULY 15TH WE

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HELD A PATIENT ADVOCATE MEETING IN SAN FRANCISCO.

AND THIS IS THE FIRST OF WHAT'S GOING TO BE A SERIES

OF MEETINGS, REGULAR MEETINGS, AROUND THE STATE

WHERE WE REACH OUT TO THE PATIENT ADVOCATE COMMUNITY

AND GIVE THEM A CHANCE TO MEET US, TALK TO US FACE

TO FACE, AND HEAR FROM US WHAT WE'RE DOING, ABOUT

THE PROGRESS THAT'S BEING MADE IN RESEARCH, AND GIVE

THEM A CHANCE TO ASK QUESTIONS AND FIND OUT AND TELL

US WHAT THEY THINK WE CAN DO BETTER.

IT WAS A GREAT MEETING. THERE WERE A

NUMBER OF VERY INTERESTING PEOPLE THERE. DIANE

WINOKUR, OUR PATIENT ADVOCATE FOR ALS AND MS, WAS

THERE. WE HAD A NUMBER OF PEOPLE WHO WERE

INTERESTED IN STEM CELL RESEARCH IN GENERAL AND ALSO

REPRESENTATIVES FROM SOME FAIRLY IMPORTANT GROUPS,

LIKE THE ARTHRITIS FOUNDATION AND THE PARKINSON'S

INSTITUTE. SO IT WAS A VERY ENGAGED GROUP.

CHAIRMAN THOMAS AND SENATOR TORRES BOTH

GAVE REALLY THOUGHTFUL PRESENTATIONS ON THE RESEARCH

AND THE SCIENCE AND THE WORK THAT'S GOING ON HERE.

AND JEFF SHEEHY ALSO GAVE A REALLY THOUGHTFUL AND

EXCELLENT, I THOUGHT, DISCUSSION WITH THE WORK WE'RE

DOING IN HIV/AIDS, WHICH IS ALL THE MORE IMPRESSIVE

BECAUSE IT WAS COMPLETELY IMPROMPTU.

THE GROUP WAS ALTOGETHER, I THINK, VERY

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ENGAGED AND ASKED A LOT OF GOOD QUESTIONS, AND WE

GOT SOME REALLY GOOD IDEAS FROM THEM ON HOW WE CAN

WORK BETTER IN THE FUTURE. SO NOW WE'RE LOOKING AT

HOLDING SIMILAR EVENTS IN SACRAMENTO, L.A., AND SAN

DIEGO.

ONE OF THE ELEMENTS IN THE MEETING, THERE

WAS A LOT OF ENTHUSIASM, WAS WHEN WE TALKED TO THEM

ABOUT A WEBCAST THAT WE HELD ON ALS OR LOU GEHRIG'S

DISEASE. THE WEBCAST WAS THE FIRST TIME WE'D USED

THIS APPROACH TO REACH OUT TO A VERY SPECIFIC

PATIENT POPULATION. AND OTHER THAN A FEW TECHNICAL

PROBLEMS, IT WENT VERY WELL.

WE USED A NEW SERVICE THAT GOOGLE OFFERS

CALLED HANGOUT. IT'S QUITE SIMPLE IN MANY WAYS

WHERE YOU CAN JUST GET PEOPLE TO LOG ON AND THEY CAN

WATCH FROM THEIR COMPUTER, SEE A CONVERSATION, A

DISCUSSION GOING ON, AND LISTEN IN AND EVEN KIND OF

POSE QUESTIONS THAT CAN THEN GET ANSWERED. IN THIS

CASE IT WAS HOSTED BY MY COLLEAGUE AMY ADAMS. DIANE

WINOKUR WAS OUR PATIENT ADVOCATE. AND SHE WAS SO

GOOD, WE'RE ASKING HER TO STUDY UP ON EVERY OTHER

DISEASE SO SHE CAN BE THE PATIENT ADVOCATE FOR EVERY

SINGLE OTHER HANGOUT THAT WE DO IN THE FUTURE.

IT ALSO FEATURED CLIVE SVENDSEN FROM

CEDARS-SINAI WHO HAS A DISEASE TEAM GRANT. AND I

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WANT TO GIVE A PARTICULAR SHOUT OUT TO DR. KAREN

BERRY, A CIRM SCIENCE OFFICER, WHO STOOD IN AT THE

LAST MOMENT FOR LARRY GOLDSTEIN AND DID A TERRIFIC

JOB. SHE WAS REALLY GREAT.

BUT RATHER THAN DRONE ON AT LENGTH, I'D

LIKE TO ACTUALLY SHOW YOU WHAT THIS VIDEO LOOKED

LIKE.

(THE VIDEO WAS THEN SHOWN, BUT NOT

REPORTED NOR HEREIN TRANSCRIBED.)

MR. MC CORMACK: TOLD YOU SHE WAS

WONDERFUL. SHE WAS GREAT. I MEAN THE WHOLE THING

WAS ACTUALLY A LOT OF FUN. AND I THINK ONE OF THE

NICE THINGS ABOUT USING THAT SERVICE, THE HANGOUT,

IS THAT AS SOON AS THE WEBCAST IS COMPLETED, IT'S

POSTED ONTO YOUTUBE. SO IT BECOMES A RESOURCE THAT

CAN BE USED OVER AND OVER AGAIN. WITHIN MINUTES OF

GOING UP ON YOUTUBE, THE NATIONAL ALS ASSOCIATION

LOCAL CHAPTERS AND OTHER MEMBERS HAD BEEN TWEETING

IT AND PUTTING IT ON THEIR SOCIAL MEDIA SITES AND

KIND OF SPREADING THE WORD. SO NOW ANY TIME SOMEONE

GOES TO LOOK AT IT, THEY LEARN ABOUT CIRM, THEY

LEARN ABOUT THE WORK THAT WE'RE DOING.

DR. VUORI: DO YOU NEED A GOOGLE PLUS

ACCOUNT FOR --

MR. MC CORMACK: YES. YES, YOU DO. IT'S

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VERY EASY TO SET UP. NO, NOT TO WATCH IT. JUST TO

BE ONE OF THE GUESTS ON THAT.

WE ALSO FOUND THAT THE FORBES NORRIS ALS

CLINIC AT CALIFORNIA PACIFIC MEDICAL CENTER TOLD US

THAT WHENEVER THEY GET REQUESTS FOR INFORMATION

ABOUT STEM CELLS, THEY SIMPLY REFER THEM TO THE

VIDEO ON YOUTUBE. SO AGAIN, IT'S A RESOURCE THAT IS

USED OVER AND OVER AGAIN. SO IT'S A GREAT TOOL THAT

WE'RE GOING TO BE USING LOTS IN THE FUTURE. AND

WHAT'S NICE AS WELL IS THAT IT'S FREE. SO WE LOVE

THAT.

AFTER SHOWING THE VIDEO CLIP AT THE

PATIENT ADVOCATE MEETING, A NUMBER OF THE PEOPLE

THERE ASKED US TO WORK WITH THEM ON DOING SIMILAR

THINGS. AND ULTIMATELY OUR GOAL IS TO HAVE SIMILAR

WEBCASTS FOR ALL OUR DISEASE TEAMS AND REALLY ANY

GROUP, ANY DISEASE AREA THAT WE PROVIDE SUBSTANTIAL

FUNDING TO BECAUSE IT'S SUCH A USEFUL TOOL TO BE

ABLE TO KIND OF REACH OUT TO DIFFERENT MEMBERS,

DIFFERENT PEOPLE, DIFFERENT AUDIENCES IN A VERY,

VERY TARGETED WAY.

AS PRESIDENT TROUNSON AND CHAIRMAN THOMAS

MENTIONED EARLIER, THERE'S BEEN KIND OF A REAL

EMPHASIS ON YOUTH LATELY AS WELL. TWO WEEKS AGO WE

HAD THE BRIDGES TRAINING MEETING, WHICH IT'S ALWAYS

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FUN TO HANG OUT WITH THESE STUDENTS OR THIS KIND OF

NEXT GENERATION OF RESEARCHERS. WE ALSO GOT A

CHANCE TO DO A WORKSHOP WITH A LOT OF BRIDGES

STUDENTS USING OUR ALMOST AWARDING WINNING ELEVATOR

PITCH CHALLENGE TO HELP THEM UNDERSTAND HOW TO

BETTER COMMUNICATE WITH THE PUBLIC. AND THEY WERE

GREAT. THEY WERE REALLY ENTHUSIASTIC, AND IT WAS

FUN TO WORK WITH THEM. THEY'RE JUST SO KEEN. SO

THAT'S ALWAYS INSPIRING.

AND THE WEEK BEFORE THAT THERE WAS A

WONDERFUL EVENT AT USC FOR OUR CREATIVITY PROGRAM,

WHICH OFFERS HIGH SCHOOL STUDENTS A CHANCE TO DO

INTERNSHIPS, SUMMER INTERNSHIPS, AT SOME WORLD-CLASS

LABS. AND DEAN PULIAFITO, WHO WAS HERE EARLIER, WAS

A GRACIOUS HOST, HONORED BOTH SENATOR TORRES AND THE

STEM CELL AGENCY. AND IT WAS GREAT, SOME WONDERFUL

SPEECHES. BUT AS ELOQUENT AS MANY OF THE ADULTS

WERE, IT WAS THE KIDS, OF COURSE, WHO STOLE THE

SHOW. I HAVE NO IDEA WHO THAT WOMAN IN THE MIDDLE

IS, BUT SHE KEPT JUMPING INTO ALL THE PHOTOGRAPHS.

IT'S MARIA.

I THINK A LOT OF THE KIDS WERE SURPRISED

BECAUSE THEY SAID THEY ASSUMED, BECAUSE THEY WERE

HIGH SCHOOL STUDENTS, THAT THEY REALLY WOULDN'T BE

ALLOWED TO DO AN AWFUL LOT. THEY ASSUMED THAT

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THEY'D BE SITTING IN THE LAB AND KIND OF WATCHING,

BUT NOT REALLY ENGAGED. AND THEY WERE DELIGHTED TO

FIND OUT THAT THEY WERE DOING EXPERIMENTS. THEY

WERE GIVEN CELLS TO CULTURE. THEY WERE GIVEN

EXPERIMENTS TO DO. AND THEY'RE REALLY ENTHUSIASTIC.

THEY REALLY GOT INTO IT.

THIS IS DARIEN HARE (PHONETIC). NOW,

DARIEN IS A STUDENT AT LIFELINE EDUCATION CHARTER

SCHOOL. AND HE SAID, "I HAD NO CLUE THAT WITH ONE

CELL YOU CAN GET SO MUCH OUT OF IT. SO IT'S

ACTUALLY OPENED MY MIND TO SEE WHAT ELSE I CAN GET

OUT OF LIFE." NOW, DARIEN, WHEN HE SIGNED UP FOR

THIS, DIDN'T REALLY KNOW AN AWFUL LOT ABOUT STEM

CELLS, BUT HE SAID AFTERWARDS HE'S JUST REALLY -- HE

FINDS SCIENCE FASCINATING NOW AND IT'S REALLY

CHANGED THE WAY HE THINKS ABOUT SCIENCE IN GENERAL.

DARIEN ALSO SAID THAT HE DIDN'T KNOW THAT

YOU HAD TO KEEP YOUR WORK SPACE REALLY, REALLY

CLEAN. AND HE SAID HE FOUND IT STRANGE THAT HE

SPENT PROBABLY AS MUCH TIME TIDYING UP HIS WORK AREA

AS HE DID DOING THE EXPERIMENTS. AND AS CHAIRMAN

THOMAS SAID, I'D HATE TO SEE HIS BEDROOM.

ANOTHER STUDENT, LYNN WANG, LYNN COMES

FROM MIRACOSTA HIGH SCHOOL, SAID THE COURSE HAD SOME

SURPRISES, SAYING, "NO MATTER WHAT YOUR TEXTBOOK

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SAYS, CELLS ARE NOT COLOR CODED." SO THAT'S A

LITTLE BIT DISAPPOINTING. BUT THEN SHE ADDED THAT

THE SECOND THING I LEARNED IS THAT SCIENCE DOES

ULTIMATELY IMPACT THE PEOPLE OUTSIDE THE LAB.

THE STUDENTS WERE ALL INSPIRING, AND SO

ALL SUMMER LONG WHAT WE'RE DOING IS WE'RE TRYING TO

ENGAGE THEM AND KIND OF TAP INTO THAT LEVEL OF

EXCITEMENT AND ENTHUSIASM BY GETTING THEM TO SEND US

PHOTOS AND VIDEOS AND BLOGS SO THAT WE CAN POST THEM

ON OUR WEB SITE AND SHARE IT WITH OTHER PEOPLE. AND

IF YOU DON'T THINK THEY'RE ALSO HAVING FUN WHILE

THEY'RE DOING THAT, I WANT TO SHOW YOU A VIDEO NOW.

THIS IS A VIDEO MADE BY TWO CREATIVITY STUDENTS WHO

WERE STUDYING AT CHILDREN'S HOSPITAL AND RESEARCH

INSTITUTE IN OAKLAND, SO IT'S A SHAME BERT LUBIN

ISN'T HERE TO SEE THIS.

IN IT THEY MAKE UP THEIR OWN LYRICS FOR A

SONG ABOUT THE WORK IN THE LAB. AND WHILE THE

LYRICS AREN'T ALWAYS EASY TO MAKE OUT, I THINK THEIR

ENTHUSIASM IS.

APPARENTLY IT'S A PLAY ON THE CUP SONG BY

NANA KENDRICK.

(VIDEO WAS THEN SHOWN, NOT REPORTED

NOR HEREIN TRANSCRIBED.)

MR. MC CORMACK: AMY INFORMS ME THAT'S

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ALSO FROM THE MOVIE PITCH PERFECT NOW PLAYING AT

LOCAL THEATERS. WELL, ACTUALLY IT'S NOT.

SO AS YOU CAN SEE, IT'S ALWAYS FUN SEEING

THESE KIND OF VIDEOS AND BLOGS COME IN BECAUSE

THEY'RE JUST SO ENTHUSIASTIC. AND SO WE'VE BEEN

HAVING A GOOD TIME KIND OF SEEING THEM COMING IN AND

THEN POSTING THEM ON OUR ALL SOCIAL MEDIA SITES.

AND THAT LEADS ME QUITE NEATLY TO WHAT'S

COMING UP AT AN UPCOMING BOARD MEETING, WHICH IS AMY

ADAMS WHO'S GOING TO BRING AN UPDATE ON ALL THE

CHANGES WE'VE MADE TO OUR WEB SITE OVER THE LAST

YEAR AND HOW WE'RE USING SOCIAL MEDIA IN DIFFERENT

WAYS NOW TO TRY AND GET OUT TO A DIFFERENT AUDIENCE

AND TO INCREASE THE NUMBER OF PEOPLE WHO ARE COMING

TO OUR WEB SITE AND LEARNING ABOUT THE WORK THAT WE

DO.

SO THANK YOU. AND WITH THAT, I'M HAPPY TO

ANSWER ANY QUESTIONS. SPEECHLESS. I LIKE THAT.

CHAIRMAN THOMAS: THAT WAS A GREAT REVIEW

OF A LOT OF REALLY GOOD EVENTS.

MR. MC CORMACK: YEAH. THEY WERE FUN.

CHAIRMAN THOMAS: I THINK IT'S ALL PART OF

GETTING THE MESSAGE MORE AND MORE OUT TO THE PUBLIC.

SO VERY NICE WORK, KEVIN AND THE REST OF THE

COMMUNICATIONS TEAM.

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ARE THERE ANY OTHER ITEMS THAT ANYBODY

WOULD LIKE TO BRING UP HERE, BOARD MEMBERS OR

MEMBERS OF THE PUBLIC? IN THAT CASE, THE ICE CREAM

SANDWICHES HAVE YOUR NAMES ON THEM.

JAMES WANTED ME TO POINT OUT THAT IN HONOR

OF DUANE, HE'S WEARING A VERY THIN TIE. AND DR.

STEWARD WANTED TO POINT OUT THAT HE IS LIKEWISE

HONORING DUANE BY BEING EVEN MORE SARTORIAL AND

ACTUALLY WEARING A SUIT TO TODAY'S MEETING. FIRST

TIME EVER. SO ON THAT NOTE AND OUR CONTINUED BEST

WISHES TO DUANE, THANK YOU, EVERYBODY. AND WE WILL

SEE YOU LATE AUGUST.

(THE MEETING WAS THEN CONCLUDED AT

2:34 P.M.)

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REPORTER'S CERTIFICATE

I, BETH C. DRAIN, A CERTIFIED SHORTHAND REPORTER IN AND FOR THE STATE OF CALIFORNIA, HEREBY CERTIFY THAT THE FOREGOING TRANSCRIPT OF THE PROCEEDINGS BEFORE THE INDEPENDENT CITIZEN'S OVERSIGHT COMMITTEE OF THE CALIFORNIA INSTITUTE FOR REGENERATIVE MEDICINE IN THE MATTER OF ITS REGULAR MEETING HELD AT THE LOCATION INDICATED BELOW

HILTON SAN FRANCISCO AIRPORT BAYFRONT 600 AIRPORT BOULEVARD BURLINGAME CALIFORNIA

ON JULY 25, 2013

WAS HELD AS HEREIN APPEARS AND THAT THIS IS THE ORIGINAL TRANSCRIPT THEREOF AND THAT THE STATEMENTS THAT APPEAR IN THIS TRANSCRIPT WERE REPORTED STENOGRAPHICALLY BY ME AND TRANSCRIBED BY ME. I ALSO CERTIFY THAT THIS TRANSCRIPT IS A TRUE AND ACCURATE RECORD OF THE PROCEEDING.

BETH C. DRAIN, CSR 7152BARRISTERS' REPORTING SERVICE160 S. OLD SPRINGS ROAD SUITE 270ANAHEIM, CALIFORNIA(714) 444-4100

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